New bla. Navigating FDA Drug Applications: A Comprehensive Guide to IND, NDA, BLA, ANDA, and OTC Processes

What are the main types of FDA drug applications. How does the IND process work. What is required for an NDA submission. How does a BLA differ from an NDA. What is the purpose of an ANDA. How are OTC drugs regulated by the FDA.

Understanding the FDA Drug Application Landscape

The United States Food and Drug Administration (FDA) oversees a complex system of drug applications designed to ensure the safety and efficacy of pharmaceuticals and biologics. These applications fall into two primary categories: those seeking authorization for clinical investigations and those requesting marketing approval. Let’s explore the five common types of FDA drug applications and their unique characteristics.

Investigational New Drug (IND) Application: The Gateway to Clinical Trials

The Investigational New Drug (IND) application serves as the critical first step in bringing a new drug to market in the United States. Its primary purpose is to safeguard the well-being and rights of clinical trial participants.

Types of IND Applications

• Commercial INDs: Aimed at developing drugs or biologics for eventual marketing
• Research INDs: Focused on non-commercial investigations for research purposes
• Emergency INDs: Expedited applications for life-threatening conditions with no standard treatment

What does an IND application include? An IND must contain information about:

1. The quality and nonclinical safety of the investigational product
2. The proposed clinical protocol
3. Details about the investigator

Beyond enabling clinical investigations, the IND also provides a legal framework for transporting investigational products across state lines, which is otherwise prohibited for non-marketed drugs.

New Drug Application (NDA): The Path to Market for Small Molecule Drugs

The New Drug Application (NDA) represents a formal request to market a new drug in the United States. Typically regulated by the FDA’s Center for Drug Evaluation and Research (CDER), the NDA aims to demonstrate the safety and effectiveness of a drug while proving that its benefits outweigh potential risks.

Key Components of an NDA

What must be included in an NDA submission? The application should provide comprehensive information on:

• Primary data, reports, and summaries of nonclinical and clinical studies
• Pharmacokinetic and pharmacodynamic analyses
• Characterization of drug ingredients and impurities
• Detailed descriptions of manufacturing processes and quality control parameters
• Proposed labeling for the drug (package insert)

The NDA builds upon the data collected during the IND phase but is significantly more comprehensive, offering a complete picture of the drug’s profile.

Biologics License Application (BLA): Regulating Biological Products

For biological products, the Biologics License Application (BLA) serves as the equivalent of an NDA. Typically overseen by the FDA’s Center for Biologics Evaluation and Research (CBER), a BLA requests permission to introduce a biologic product into interstate commerce.

Biological Products Subject to BLAs

Which products require a BLA? Examples include:

• Monoclonal antibodies for in vivo use
• Cytokines and growth factors
• Enzymes and immunomodulators
• Thrombolytics and therapeutic proteins
• Non-vaccine immunotherapies

Similar to an NDA, a BLA must provide detailed information on manufacturing processes, chemistry, pharmacology, clinical pharmacology, and the medical effects of the biological product.

Abbreviated New Drug Application (ANDA): Streamlining Generic Drug Approval

The Abbreviated New Drug Application (ANDA) is designed specifically for the review and approval of generic drug products. Regulated by the FDA’s Office of Generic Drugs (OGD), ANDAs follow a streamlined process compared to full NDAs.

ANDA Requirements and Process

How does an ANDA differ from an NDA? The key distinction lies in the data requirements:

• ANDAs generally do not require preclinical (animal) and clinical (human) data to establish safety and effectiveness
• Instead, they focus on demonstrating that the generic product performs in the same manner as the innovator drug
• Bioequivalence studies are typically required to show that the generic drug delivers the same amount of active ingredient in the same timeframe as the brand-name counterpart

This abbreviated process allows for faster and more cost-effective development of generic drugs, ultimately benefiting consumers through increased access to affordable medications.

Over-the-Counter (OTC) Drug Regulation: A Unique Approach

Over-the-Counter (OTC) drugs follow a distinct regulatory pathway compared to prescription medications. The FDA employs two primary mechanisms for OTC drug regulation:

OTC Drug Monograph System

What is an OTC drug monograph? It’s a “recipe book” covering acceptable ingredients, doses, formulations, and labeling for OTC drugs. Products that conform to an established monograph can be marketed without further FDA review.

NDA Process for OTC Drugs

In cases where an OTC drug doesn’t fit within an existing monograph, manufacturers must follow the NDA process. This applies to:

• Novel OTC products
• OTC drugs with new ingredients or combinations
• Products seeking to switch from prescription to OTC status

The dual approach to OTC regulation allows for both efficient marketing of established OTC products and careful evaluation of new or innovative OTC medications.

Navigating the FDA Application Process: Key Considerations

Successfully navigating the FDA drug application process requires careful planning, thorough documentation, and a deep understanding of regulatory requirements. Here are some critical factors to consider:

Early Engagement with the FDA

Why is early communication with the FDA crucial? Engaging with the agency early in the development process can:

• Provide clarity on regulatory expectations
• Help identify potential issues before they become roadblocks
• Guide study design and data collection strategies
• Potentially streamline the application process

Quality of Data and Documentation

The success of any FDA application hinges on the quality and completeness of the submitted data. How can applicants ensure their submissions meet FDA standards?

• Implement robust quality control measures throughout the development process
• Ensure all studies adhere to Good Laboratory Practices (GLP) and Good Clinical Practices (GCP)
• Maintain detailed and accurate records of all development activities
• Present data clearly and logically, with comprehensive analyses and interpretations

Understanding Review Timelines

Each application type has its own review timeline, which can impact development and commercialization strategies. What are the typical review periods for different applications?

• IND: 30 days for initial review
• NDA and BLA: 6-10 months, depending on the review designation
• ANDA: 8-10 months for standard review
• OTC Monograph: Varies depending on the specific monograph and any proposed changes

Understanding these timelines allows companies to better plan their development strategies and resource allocation.

Emerging Trends in FDA Drug Applications

The landscape of FDA drug applications is continually evolving, influenced by scientific advancements, public health needs, and regulatory innovations. What are some of the emerging trends shaping the future of drug applications?

Expedited Review Programs

The FDA has introduced several programs to accelerate the development and review of drugs for serious conditions:

• Fast Track Designation
• Breakthrough Therapy Designation
• Accelerated Approval
• Priority Review

These programs aim to bring innovative therapies to patients more quickly while maintaining the FDA’s high standards for safety and efficacy.

Real-World Evidence and Patient-Focused Drug Development

How is the FDA incorporating real-world data into the drug approval process? There’s a growing emphasis on:

• Using real-world evidence to support regulatory decision-making
• Incorporating patient experiences and preferences into drug development and review
• Developing novel clinical trial designs that better reflect real-world conditions

This shift towards more patient-centric and real-world-oriented approaches is reshaping how companies design their development programs and structure their FDA applications.

Advanced Therapeutics and Personalized Medicine

The rise of advanced therapeutics, such as cell and gene therapies, and the growing field of personalized medicine are challenging traditional regulatory frameworks. How is the FDA adapting to these new modalities?

• Developing new guidance documents for novel therapeutic approaches
• Creating specialized review teams for advanced therapies
• Exploring innovative clinical trial designs for personalized treatments
• Considering new approaches to manufacturing and quality control for complex biologics

These advancements are pushing the boundaries of traditional drug applications, requiring both regulators and industry to adapt and innovate.

Navigating Regulatory Challenges in FDA Drug Applications

While the FDA drug application process is designed to ensure the safety and efficacy of new medications, it can present significant challenges for applicants. Understanding these challenges and developing strategies to address them is crucial for success.

Complexity of Regulatory Requirements

The regulatory landscape for drug development is intricate and ever-changing. How can companies stay abreast of current requirements?

• Regularly review FDA guidance documents and regulations
• Attend FDA workshops and industry conferences
• Consider engaging regulatory consultants or building in-house expertise
• Participate in pre-submission meetings with the FDA to clarify expectations

Data Management and Submission Logistics

FDA applications require vast amounts of data, which must be organized, analyzed, and presented effectively. What strategies can help manage this data deluge?

• Implement robust data management systems early in the development process
• Utilize electronic submission tools and formats (e.g., eCTD)
• Conduct thorough quality checks on all data before submission
• Develop clear data narratives that guide reviewers through complex datasets

Addressing FDA Queries and Requests

During the review process, the FDA often requests additional information or clarification. How can applicants effectively manage these interactions?

• Respond promptly and comprehensively to all FDA queries
• Maintain open lines of communication with review teams
• Be prepared to provide additional analyses or conduct new studies if required
• Consider the potential impact of responses on future regulatory interactions

By anticipating and preparing for these challenges, companies can navigate the FDA drug application process more smoothly and increase their chances of successful outcomes.

The Future of FDA Drug Applications: Adapting to a Changing Landscape

As science and technology continue to advance, the FDA drug application process is likely to evolve. What changes might we see in the coming years?

Integration of Artificial Intelligence and Machine Learning

How might AI and ML impact drug development and regulatory processes?

• Enhanced predictive modeling for drug safety and efficacy
• Improved analysis of complex datasets, including real-world evidence
• Streamlined review processes through automated data validation and analysis
• Novel clinical trial designs leveraging AI for patient selection and monitoring

Global Harmonization Efforts

As drug development becomes increasingly global, what steps are being taken to harmonize regulatory processes?

• Continued collaboration through the International Council for Harmonisation (ICH)
• Development of common data standards and submission formats
• Exploration of joint review processes between regulatory agencies
• Efforts to align regulatory requirements for emerging technologies and therapies

Adaptive Licensing and Progressive Approval Pathways

Could we see more flexible approaches to drug licensing in the future?

• Iterative approval processes based on accumulating evidence
• Conditional approvals with ongoing data collection requirements
• Integration of post-market surveillance data into regulatory decision-making
• Tailored approval pathways for different therapeutic areas or patient populations

As the FDA continues to adapt to scientific advancements and evolving public health needs, we can expect the drug application process to become more sophisticated, data-driven, and patient-centric. Companies that stay abreast of these trends and proactively engage with regulatory authorities will be best positioned to navigate the changing landscape of FDA drug applications.

5 Common Types of FDA Drug Applications: Quick Guide

There are two broad application categories for drugs and biologics regulated by the United States Food and Drug Administration (FDA):

1. Requests for authorization for clinical investigations
2. Requests for marketing approval

The Investigational New Drug (IND) application falls into the first category, while the New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) fall into the second category. Over-the-Counter (OTC) drugs are regulated slightly differently, either by conformance with an established OTC drug monograph or via the NDA process. Here we describe the differences between these application types and some of the regulatory processes and considerations associated with them.

1. Investigational New Drug Application (IND)

The IND is the launching point for clinical investigations in the United States and is an essential step along the path toward getting a new drug on the market. From the FDA’s perspective, the primary purpose of an initial IND submission is to ensure, as much as possible, the safety and rights of clinical trial participants.

Besides allowing clinical investigations, the IND also performs an additional legal function. Because federal law states that only marketed drugs are permitted to be transported across states lines, the IND provides a legal framework that allows Sponsors to transport their investigational products to clinical investigators in different states.

INDs may be categorized as either commercial or research. Commercial INDs allow for the development of a drug or biologic with the goal of ultimately submitting a marketing application. Research INDs involve therapies that are not intended for commercialization but are being investigated strictly for research purposes (e.g., to generate a publication or evaluate a potential mechanism).

In addition to these two primary designations, emergency INDs (a type of expanded access IND application) may be submitted by physicians to allow treatment of immediately life-threatening conditions when no standard acceptable treatment is available and insufficient time exists to receive Investigational Review Board (IRB) approval. Emergency INDs act upon a different timeline than other types of INDs.

Regardless of the type of IND, all IND applications must include information about the quality and nonclinical safety of the investigational product as well as the proposed clinical protocol and investigator.

2. New Drug Application (NDA)

The NDA is a formal request made by a Sponsor to market a new drug in the United States. NDAs are typically regulated by FDA’s Center for Drug Evaluation and Research (CDER).

The goals of the NDA are to provide enough evidence to support the safety and effectiveness of the drug and to show that the benefits of its use outweigh the risks. In addition, the FDA will review the proposed labeling for the drug (i.e., package insert) and determine if the manufacturing methods maintain the drug’s identity, strength, quality, and purity.

Data collected during the IND phase of the development program will become part of the NDA. However, the NDA is much more comprehensive than the IND and is expected to provide very detailed information about the drug. This includes primary data, reports, and summaries of the results of the nonclinical and clinical studies, analyses related to the body’s effect on the drug and the drug’s effect on the body (PK/PD), characterization of the drug’s ingredients and impurities (including any potential toxicities), and a description of all manufacturing processes and quality control parameters.

3. Biologic License Application (BLA)

Just as an NDA does for a small molecule drug (and select other classes), the BLA is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. BLAs are typically regulated by FDA’s Center for Biologics Evaluation and Research (CBER).

Similar to an NDA, the BLA contains specific and detailed information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and the medical effects of the biological product.

Examples of biological products that would be subject to BLAs include monoclonal antibodies for in vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, therapeutic proteins, and non-vaccine immunotherapies.

4. Abbreviated New Drug Application (ANDA)

An ANDA is submitted to the FDA for the review and approval of a generic drug product. ANDAs are regulated by FDA’s Office of Generic Drugs (OGD) and are considered abbreviated, as they generally are not required to include pre-clinical (animal) and clinical (human) data to establish safety and effectiveness.

Instead, an ANDA only needs to demonstrate that the generic product performs in a similar manner to the reference marketed drug (commonly referred to as the Reference Listed Drug [RLD]) that appears in FDA’s Orange Book. Specifically, the generic drug must deliver the same amount of active ingredients into the bloodstream in the same amount of time as the reference product (this is known as bioequivalence) or it must demonstrate therapeutic equivalence if not bioavailable.

Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low-cost alternative to the branded product.

5. Over-the-Counter (OTC) Application

Over-the-counter (OTC) drugs are defined as drugs that are safe and effective for use by the general public without needing a prescription from a health care professional. FDA’s review of OTC drugs is primarily handled by FDA’s Office of Nonprescription Drugs (ONPD).

There are two pathways by which marketing of OTC products may be achieved:

1. Compliance with an OTC drug monograph
2. Approval under an NDA or ANDA

An OTC monograph is a set of regulatory standards for different therapeutic drug classes that includes acceptable ingredients, doses, formulations, and labeling requirements. If the standards of an applicable OTC monograph are met, marketing pre-clearance is not required by the FDA. If the OTC drug deviates from the final monograph, however, a formal marketing application (e.g., NDA) or citizen petition may be used to request approval.

Conclusions

It is important to understand the various types of drug applications and when each application is necessary. Nuventra consultants have extensive experience across the various application types and approval pathways for a wide variety of drugs and biologics. If you aren’t sure which application you need or if you need help authoring, reviewing, or submitting an application – we can help. Contact us today to see how we may assist with your drug development needs!

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Regulatory Differences For Market Approval

To formally request approval to market a new drug in the United States, Sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the FDA. As their names suggest, BLAs relate to biological products while NDAs generally pertain to traditional small molecule drugs. While they share the same goal of obtaining marketing approval, they also vary slightly in content and scope. In this post, we explore the similarities and differences between the two marketing applications, as well as special considerations based on recent regulatory changes.

What are New Drug Applications (NDA) & Biologics License Applications (BLA)?

An NDA is an application to permit the sale and marketing of a new drug in the United States. A traditional NDA consists of data and information about the drug as gained from both nonclinical and clinical studies, as well as a summary of formulation development and manufacturing processes, and proposed labeling information to be included in the drug’s packaging.

In general, an NDA should contain enough data for the FDA to determine if the drug is safe and effective for its proposed use, if the benefits of taking the drug outweigh the risks, and if the drug product is manufactured in a way that preserves its identity, strength, quality, and purity. Drugs that are approved via an NDA pathway are regulated under Section 505 of the Food, Drug, & Cosmetics (FD&C) Act.

A BLA is a request to introduce, or deliver for introduction, a biological product into interstate commerce. Like an NDA, a BLA should include all information about the biological product that was gained over the development process and should demonstrate the biologic’s safety, purity, and potency. The BLA also contains the proposed labeling information to be included in the drug’s packaging.  Per the Biologics and Price Competition and Innovation (BPCI) Act of 2009, as of March 23^rd, 2020, all biological products must be approved through the BLA pathway, and therefore will be licensed under Section 351 of the Public Health Service (PHS) Act, in addition to being regulated by the FD&C Act.

What is a Biological Product?

Biological products are a subset of drugs defined by Section 351 of the PHS Act as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, … applicable to the prevention, treatment, or cure of a disease or condition of human beings.” The definition was later amended by the BPCI Act of 2009 and the Further Consolidated Appropriations Act of 2020 to include proteins (excluding peptides). Because biological products are typically derived from living systems, their large, complex structures are often difficult to characterize. This is a key distinction from traditional drug molecules, which are chemically synthesized and structurally both simpler and smaller in size.

The manufacturing process for biological products is also more complicated, due to genetic variability in the source material. Because of this, it is critical that BLAs contain a thorough description of product development and relevant manufacturing procedures, as well as all steps taken to ensure that the final biological product performs consistently across batches.

Key Differences Between BLAs & NDAs

While BLAs and NDAs serve the same purpose of gaining approval to market a drug in the United States, they differ slightly in terms of their application content and submission requirements. Regarding approval criteria, NDAs must fulfill three conditions:

• The drug is safe and effective for the proposed use and that the benefits outweigh the risks
• The labeling is appropriate and contains all necessary information about the drug
• Manufacturing methods preserve the drug’s identity, strength, quality, and purity

Similarly, contents of a BLA should establish that the biological product is safe and potent; however, because biological products are processed from living material, BLA content must also demonstrate purity specifically in terms of showing that the final product does not contain extraneous material.

Due to the complexities of manufacturing biological products, a pre-license inspection of the facility is generally required before a BLA is approved. Pre-approval inspections sometimes also take place during an NDA review, but are typically conducted based on risk assessment by the Agency.

Once a BLA is approved, the Sponsor is granted a license for the biological product, which permits its introduction into interstate commerce per Section 351 of the PHS Act. This licensing process is not a part of the NDA, as drugs that are approved by NDA are regulated only by the FD&C Act, and not the PHS Act.

Until very recently, certain biological products could be approved under an NDA rather than a BLA. However, according to the Biologics Price Competition and Innovation Act (further discussed below) this is no longer the case, and all biological product approvals now occur through a BLA.

Regulatory Agencies

There are two Centers within the FDA that are responsible for the review and approval of drug marketing applications and general regulatory oversight: the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). While all conventional drug products (i.e., small molecules) are regulated by CDER, biological products can be regulated by either CDER or CBER, depending on the product’s classification as discussed above.

The majority of BLA submissions are assigned to CBER; however, BLAs for certain biological product categories are reviewed by CDER instead. These product categories include monoclonal antibodies for in vivo use, most proteins for therapeutic use (e.g., cytokines, enzymes, and other novel proteins except those assigned to CBER, such as vaccines and blood products), immunomodulators, and growth factors. Regardless of the category, NDAs for all drug products fall under the jurisdiction of CDER.

Key Similarities Between BLA & NDA

Like an NDA, a BLA is submitted to the FDA in order to market a new drug in the US. As they share the same goal of obtaining marketing approval, NDAs and BLAs are similar in that both must contain enough information to demonstrate the efficacy and safety of the drug, as well as demonstrate an ideal risk:benefit ratio, in order to be successful. Additionally, many of the same regulations apply to NDAs and BLAs, including labeling and advertising rules, accelerated approval pathways, pediatric study requirements, and PDUFA fees.

Regardless of whether a Sponsor is submitting an NDA or BLA, the same pre-marketing regulations apply. This includes initial filing of an IND and subsequent maintenance of the IND throughout the drug development program until the marketing application is submitted. The structure and contents of the IND do not differ between drugs and biological products.

Biologics Price Competition and Innovation Act

It is important to note that on March 23, 2020, the Biologics Price Competition and Innovation (BPCI) Act went into effect. Along with introducing an abbreviated approval pathway for highly similar biological products (i.e., biosimilars), this act mandated that moving forward, all biological products must be submitted for marketing approval through a BLA, and not an NDA. For biological products that had been previously approved via NDA (e. g., protein products), the approved marketing application will be “deemed to be a license” (i.e., serve as an approved BLA) for the biological product under Section 351 of the PHS Act.

Conclusions

NDAs and BLAs are the two types of applications that are submitted in order to market a new drug in the United States. While they are both submitted to gain FDA drug approval, they differ in terms of product categories, approval criteria, and certain regulations. Nuventra consultants are widely experienced in the preparation and submission of both BLAs and NDAs for numerous drugs and indications.

If you have questions about preparing your marketing application or need assistance with its development, Nuventra is here to help. Contact us today to see how we can support you on your pathway to FDA approval.

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The Biologics License Application (BLA) Process Explained

A biologics license application (BLA) is a request to distribute a biologic across states.

It generally is submitted after an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) and after the appropriate studies have been conducted.

A biologics license application generally applies to vaccines and other allergenic drug products, blood products, and cellular and genetic therapies.

We’ve briefly outlined the BLA process below. Of course, planning and executing this process is an extremely involved and complex initiative requiring coordination, diligence, and domain expertise in several areas.

Contact us if you’d like to discuss expert consulting assistance from some of the top regulatory talent across the industry. We’ve helped many companies—big and small—plan and navigate the BLA process successfully, on time and on budget. 

1. Apply for a Biologics License Application

Anyone who is involved in the manufacture of biologics or who takes responsibility for the regulatory compliance of a biologic can apply for a biologics license application. Applicants should identify a review committee and arrange a meeting with the Food and Drug Administration (FDA) before they submit the application.

They also should schedule a bioresearch monitoring inspection. When determining the timing of the submission, they should consider the schedule and needs of the advisory committee. In some cases, the manufacturer may also want to consider whether they want submit a validation plan for the FDA to review or to meet with the FDA regarding the validation plan before they submit the application.

Read Also: What Makes for a Good Validation Master Plan?

2. Submit a Form FDA 356h

Next, applicants must submit a Form FDA 356h to the document control center at the Center for Biologics Evaluation and Research (CBER), a division of the FDA that specifically handles biologics.

Both paper and electronic submissions are acceptable. However, as with New Drug Applications (NDA), an electronic Common Technical Document (eCTD) can be used to submit a biologics license application.

A Form FDA 356h is an application to market a new drug, biologic, or antibiotic drug for use in humans.

The Form FDA 356h contains the following information:

• A summary of information submitted as part of the application.
• Information on the applicant submitting the biologics license application.
• A preclinical data section.
• A clinical data section that includes safety and efficacy data on the product.
• Draft labeling of the product to be licensed.
• Information on the manufacturing, chemistry, and controls of the product.
• A data summary of validation of important processes and assays involved in the manufacture of the product.
• A description of the facility where the product is manufactured.
• Case report form tabulations on the manufacturer’s clinical experience with the product.
• Case report forms and serious event narratives.
• An index.

The information on the chemistry, manufacturing, and controls should also contain copies of important standard operating procedures related to the manufacture of the drug.

In some cases, manufacturers are required to submit information regarding whether they are ready for an inspection by the FDA.

Need expert assistance with FDA inspection readiness? Learn more about our auditing and regulatory affairs services and contact us to discuss solutions.

3. Await FDA Review

After the FDA receives the biologics license application, they will review it to determine whether it is complete.

• This review includes an initial review of the standard operating procedures and the validation data. They will then hold a filing meeting to identity any issues that could result in issuance of a Refuse to File (RTF), such as missing data or information on the manufacturing.
• If the manufacturer has not provided all the appropriate information, the FDA will discuss what information needs to be provided by the manufacturer within 74 days. They will then issue a filing letter or a Refuse to File (RTF) on the basis of their findings.
• If they issue a filing letter, the advisory committee will then conduct a complete review. This process includes a scientific review of the data by personnel form various disciplines and can vary on the basis of the compound submitted and the manufacturing process involved. In some cases, the FDA may request a prelicensing inspection to verify that the manufacturer is in compliance with the appropriate regulations.
• They may also request additional information from the manufacturer as appropriate. In some cases, a discipline review letter may be issued after personnel from a given discipline have completed their review but before the entire review has been completed.
• After the complete review has finished, the review committee will meet and identify any issues, agreements, and other commitments.

Some of the negative outcomes that can happen include issuing a Refuse to File (RTF) and placing a hold on the Investigational New Drug (IND) or an Investigational Device Exemption (IDE).

They may also determine that the product is not ready for approval and request that the application be resubmitted. However, if the FDA approves the biologics license application, they will issue an approval letter. This approval letter authorizes the manufacturer to distribute the product and itemizes any agreements and other commitments.

Further Reading: Biologics License Applications (BLA) Process (CBER)

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Updated: Striking While the Iron is Hot: FDA Corrects New NDA, BLA Filings in Q1 of FY 2020

Posted 18 February 2020 | By Zachary Brennan 

As the US Food and Drug Administration (FDA) continues to approve more new drugs more quickly, the number of new application filings in the first quarter of FY 2020 (through 31 December 2019) seemed at first to have increased dramatically when compared to FY 2019 and 2018.

FDA initially said this latest quarter saw 74 new drug application (NDA) filings and 32 biologics license application (BLA) filings, which compared with a total of only 26 BLA filings in all four quarters of 2019 and a high of 51 NDA filings in Q1 of 2019. By comparison, FDA saw an average of 35 quarterly NDA filings across FY 2019 and 34.25 across FY 2018, while quarterly BLA filings averaged 6.5 in FY 2019 and 5.25 in FY 2018.

Five days after this article was originally published on 5 February, “On February 10, 2020, the data was updated to exclude CDER efficacy supplements (41 NDAs and 22 BLAs) that were inadvertently included in the filed counts,” FDA’s latest version of the quarterly report says. 

Peter Stein, director of the FDA’s Office of New Drugs (OND), recently spoke to Focus and noted the rise of cancer drug applications, especially for subtypes of cancers and rare cancers where there have been some “dramatic responses.” 

EMA vs. FDA

A study found that the European Medicines Agency (EMA) and FDA disagreed on approvals in only limited circumstances from 2014 to 2016, but more recently, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted negative opinions for two drugs in 2018 that were approved by FDA in 2017, and one sickle cell drug in 2019 that was also previously approved by FDA.

In addition, CHMP raised questions about Mitsubishi Tanabe Pharma’s treatment for amyotrophic lateral sclerosis, which withdrew its application this year, and which was approved by FDA in 2017. And EMA refused to approve Bristol-Myers Squibb’s Idhifa (enasidenib) based on a single-arm study and the company withdrew its application. But FDA approved the treatment in 2017.

Roche also said EMA wants more data for its spinal muscular atrophy treatment risdiplam “before approval (perhaps with broader indication) and we may have a policy difference with broad implications,” Bernstein biotech analyst Ronny Gal said in an investor note this week, pointing to differences between FDA and EMA.

FDARA Section 903 Real Time Quarterly Reports

Editor’s note: FDA provided an updated quarterly report to Focus, showing the initial Q1 statistics were inflated with supplement data. 

© 2021 Regulatory Affairs Professionals Society.

Transition to BLA Pathway Is Complete

As of today, March 23, 2020, the life sciences industry completes “the transition.” New categories of biologics will now be licensed via the biologics approval pathway under the Biologics Price Competition and Innovation Act (BPCIA).

This transition occurs 10 years after the 2009 enactment of the BPCIA. During that interim, manufacturers of certain biologics approved and under review for approval were in limbo as to how their products and rights of exclusivity would be treated under the new policy.

Now, biologics previously approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FDC) will automatically be “deemed” biologics licensed under section 351 of the Public Health Service Act (PHS). Ultimately, these drugs will be categorized as biologics, subject to biosimilar and not generic competition.

Unfortunately, the original BPCIA statute did not provide instructions to the FDA on how to implement this change. Therefore, the FDA has taken certain steps to enact the transition via several proposed rules and the implementation of its Biosimilars Action Plan (BAP).

The BAP was released in July 2018. The plan is in 2 sections. The first defines key areas in which the FDA wants to focus its regulatory efforts: improving clarity and efficiency of the biosimilar approval process, enhancing understanding through better public communications, and addressing anticompetitive practices.

The second section is made up of key actions. These are steps that the FDA is either taking or planning to take to improve review processes, create information resources, upgrade guidance, and encourage public feedback. Many of these actions have already been initiated.

On February 21, 2020, the FDA released a final rule that goes into effect today. It amends the FDA’s regulatory definition of a biological product so that it is aligned with the BPCIA. “Under the final rule, the term protein means any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.” This is one of the final steps in the 10-year transition process. It opens the door for insulins to be approved via the biologics license application (BLA) pathway.

Over 100 products that had been approved via new drug applications under the FDC now must be reviewed as BLAs under section 351 of the PHS. Drugs that will be transitioned include naturally occurring proteins such as hyaluronidase, human growth hormones, and menotropins.

The FDA is focusing on insulins and has made waves with the release of draft guidance on insulin biosimilars. The FDA indicated that switching studies may not be needed for a designation of interchangeable insulins if analytical assessments suggest high similarity between biosimilars and reference products. This could speed the arrival to market of the first interchangeable biosimilars in the United States for insulin.

The FDA has also released 2 question-and-answer documents that discuss the transition for patients and healthcare providers. With the BAP and guidance, the FDA has signaled that they are moving forward with the transition as a means of introducing more affordable medicines into the healthcare system—specifically, by expanding the use of biosimilars.

BLA Part 6 – DAVID BOWIE AT THE KIT KAT KLUB (LIVE NEW YORK 99) — David Bowie

“By the time I got to New York…”

Using a process of elimination, it’s possible that some of you saw this one coming. The news is that DAVID BOWIE AT THE KIT KAT KLUB (LIVE NEW YORK 99) will be available for pre-order this coming Friday, 19th March, on CD and double vinyl, with a release date of 2nd April.

Use this link on Friday to pre-order both BLA Part 6 and extra slipcases which will be available at the same time.

Keep reading for the full press release.

#BowieKitKatKlub #DBBLA #BrilliantLiveAdventures

+ – + – + – + – + – + – + – + – + – + – + – + – + – + – +

DAVID BOWIE AT THE KIT KAT KLUB (LIVE NEW YORK 99) TO BE RELEASED ON CD AND 2xLP 2nd APRIL

SIXTH & FINAL RELEASE IN ‘BRILLIANT LIVE ADVENTURES’ SERIES OF SINGLE PRESSING LIVE ALBUMS FROM THE 1990s

LIMITED EDITION BOXES TO HOUSE COMPLETE SETS AVAILABLE EXCLUSIVELY VIA THE DAVID BOWIE OFFICIAL STORE & WARNER MUSIC GROUP’S DIG! STORE

Parlophone Records is proud to announce DAVID BOWIE AT THE KIT KAT KLUB (LIVE NEW YORK 99), the sixth and final instalment of DAVID BOWIE ‘BRILLIANT LIVE ADVENTURES’, a series of 1990s era Bowie live albums released as limited one run only vinyl and CD pressings. The albums and limited-edition boxes to house the full vinyl or CD collections will be available only via the David Bowie official store and Warner Music Group’s Dig! store.

Out 2nd April on CD and double vinyl, DAVID BOWIE AT THE KIT KAT KLUB (LIVE NEW YORK 99) is a 12-track live album, recorded on 19th November 1999 in front of an invite-only audience of fans and contest winners.

The show was recorded and filmed for webcast the following month via Liveonline.net. The audio from the show was previously only available as a 12-track promotional CD.

DAVID BOWIE AT THE KIT KAT KLUB (LIVE NEW YORK 99) was recorded live at the Kit Kat Klub, 19th November 1999, produced by David Bowie, mixed by Mark Plati, and features Bowie backed by Page Hamilton – guitar, Gail Ann Dorsey – bass, vocals, Mark Plati – guitar, Sterling Campbell – drums, Mike Garson – piano, keyboards, synthesisers and Emm Gryner and Holly Palmer – backing vocals.

DAVID BOWIE AT THE KIT KAT KLUB (LIVE NEW YORK 99)

CD

Life On Mars?

Thursday’s Child

Something In The Air

China Girl

Can’t Help Thinking About Me

Always Crashing In The Same Car

Survive

Stay

Seven

Changes

The Pretty Things Are Going To Hell

I’m Afraid Of Americans

LP

Side 1

Life On Mars?

Thursday’s Child

Something In The Air

Side 2

China Girl

Can’t Help Thinking About Me

Always Crashing In The Same Car

Side 3

Survive

Stay

Seven

Side 4

Changes

The Pretty Things Are Going To Hell

I’m Afraid Of Americans

GNS / BALA requirements :: National Security Studies Program

Global and National Security (GNS) Concentration / Bachelors of Liberal Arts and Integrative Studies (LAISBLA) Degree, University College (UC), UNM

CLICK HERE FOR THE NEW 2018-19 BLA FLIER. And HERE for the Plan of Study.

HERE is the list of NSSP (GNS) LAIS classes for SPRING 2019.

Introduction

The Global and National Security concentration to the BLA degree is designed for students who wish to focus on analysis of global and national security issues and to their potential solutions. An understanding of the policy and technical elements of global and national trends is essential to being able to analyze issues and threats related to global and national security. To complete this concentration, students must take: basic critical thinking and quantitative analysis, a foreign (non-English) language sequence, a three credit-hour foundational course that introduces concepts of global and national security, as well as, an additional twenty-one hours of global and national security selected upper division (300 – ­499) with no more than nine (9) credits in any one area.

Students must complete all requirements for the BLA degree under LAIS in UC and complete the concentration program outlined below. Following the concentration below and the BLA requirements will constitute an acceptable BLA program under LAIS. This BLA Concentration is to be offered through University College, Liberal Arts and Integrated Studies (LAIS) Program. The concentration will be supported in UC LAIS division by a faculty advisory committee through the UNM National Security Studies Program (NSSP) which is part of the new Global and National Security Policy Institute (GNSPI). Contact the LAIS program advisors in University College at  277-0122 or NSSP advisors at 277-3223 for more program details.

A closely related certificate is also offered at UNM through UC. The National Security and Strategic Analysis (NSSA) Certificate, which has a focus on analysis of global and national security issues, is open to all undergraduate students and recent graduates.

Requirements:

1.    Basic critical thinking and quantitative analysis:

• PHIL 156 / Reasoning and Critical Thinking, (3 cr),
• STAT 145 / Intro to Statistics (3 cr) or a (3 cr) math/stat class above Stat 145 and Math 153
• CS151L / Programming Fundamentals for Non-Majors (3 cr) or higher.

2.   Nine (9) credit hours, chosen from:

• ANTH 130 / Cultures of the World
• SOC 221 / Globalization and Human Rights
• POLS 220 / Comparative Politics
• RELG 107 / Living World Religions
• AMST 185 / Introduction to Race, Class, and Ethnicity

3.  Twelve (12) credits of a single foreign (non-English) language with 6 credits above 200.

4.  Intro to Global and Nat Security LAIS 340 (3 cr). 

5.  In addition, Twenty-one (21) credit hours of Upper Division “Global and National Security Electives” chosen from the list available on the BLA / NSSP GNS website or from a BLA advisor. No more than 9 credit hours from any one area.

Shared Credit Hours between Undergraduate Certificates and Degrees:

If courses taken for an undergraduate certificate fall within the prescribed time limits for an undergraduate degree, the University allows shared course work between undergraduate certificates and a baccalaureate degree. If the student completes a certificate in conjunction with an undergraduate degree program, the student may use 100% of the certificate course work toward an undergraduate degree if it is approved as part of the degree.

Global and National Security (GNS) Concentration Electives Bachelors of Liberal Arts (BLA) Degree, University College (UC), UNM

All courses titled as “Topics”, “Seminar”, “Studies”, or “Problems” need individual approval by BLA advisor prior to enrollment to count towards the degree requirements. Other courses not listed below may be pre-approved by the BLA advisor, such as many STEM courses above 300. In either case, students should present to the advisor a description of the course indicating topics relating to global and national security.

AFAS-Aerospace Studies

300 Air Force Leadership Studies

301 Air Force Leadership Studies

AFST-Africana Studies

315  Race and the Law

317 Civil Rights Movement

329  Introduction to African Politics

397  Interdisciplinary Topics

495 Topics in Africana Studies     

AMST-American Studies

309 / 509  Topics in Social Movements

310 / 510. Topics in Cultural Studies

320 Topics in Environmental and Social Justice [Topics in Environment, Science and Technology]

350 / 550  Topics in Race, Class, Ethnicity

353 Race Relations in America

ANTH-Anthropology

330  Principles of Cultural Anthropology

333 / 533  Ritual Symbols and Behavior

339/539 Human Rights in Anthropology

340 Topics in Cultural Anthropology

343 / 543 Latin American Cultures and Societies

420 Topics in Archaeology

BIOL-Biology

310  Principles of Ecology

379  Conservation Biology

405 / 505 Ecosystem Dynamics

445 / 545 Biology of Toxins

475 / 575 Community Ecology

480 / 580 Global Change Biology

CJ-Communication and Journalism

313  EcoCultural Communication: Humans and “The Environment”

314 Intercultural Communications

317 International Cultural Conflict and Community Building

320 Conflict Management and Mediation

323 Nonverbal Communication

334 Political Communication

393 Topics in Communication and Journalism

ECON Economics

309 Introductory Statistics and Econometrics (substitute for Stat 314 requirement)

320 Labor Economics

321 Development Economics

331 Economics of Poverty and Discrimination

395 Seminar in Current Economic Issues

421 Latin American Economics

423 Topics in Latin American Development

424 International Trade

429 International Finance

Geo-Geography

352  Global Climate Change

381L  Introduction to Geographic Information Systems

450 Environmental Hazards

464 / 564 Food and Natural Resources

467 / 567 Governing the Global Environment

483L / 583L Remote Sensing Fundamentals

499 Topics in Geography

HIST History

300 / 500  Studies in History

311  World War I, 1914-1918

313 / 513 World War II and Reconstruction in Europe

341 U.S. Foreign Relations from 1900.

350 / 550 Modern U.S. Military History, 1900 to Present

403 / 603 The Russian Empire: History at the Peripheries

406 / 606 The Medieval and Modern Apocalypse

422 / 622 Modern European Imperialism

432 / 632 Explorations in Russian and Eurasian Environmental History

441/641 History of Religion in America

465 / 645 History of Mexican Immigration

469/649 Inter-American Relations

473/653 Indigenous Peoples of Latin America

481/661 Intellectual History of Islam

INTS-International Studies

499 Topics in International Studies

LTAM-Latin American Studies

400 Topics in Latin American Studies

MGMT-Management

328  International Management

421  International Entrepreneurship

450  Computer-Based Information Systems

459  Information Analysis

470  Financial Markets and Institutions

474  International Financial Management

MLSL-Army ROTC

MLSL 302/302L  Leadership in Changing Environments/Lab

MLSL 402/402L  Leadership in a Complex World/Lab

MVSC-Naval ROTC

NVSC 401  Leadership and Management

NVSC 407  Leadership and Ethics

PCST-Peace Studies

306  Peace and Conflict

307  Nonviolent Alternatives

340  Topics in Peace Studies

PHIL Philosophy

366 Chinese Philosophy

365 Philosophy of Religion

381 Philosophy of Law

POLS-Political Sciences

300 Political Topics

307 The Politics of Ethnic Groups

315 Constitutional Law: Powers

316 Constitutional Law: Liberties

317 Constitutional Law: Rights

320 Topics in Comparative Politics

329 Introduction to African Politics

340 Topics in International Politics

341 International Conflict and Cooperation

342 American Foreign Policy

346 / 512 International Political Economy

354 Introduction to Latin American Society I: Social Sciences

356 Political Development in Latin America

372 Urban Politics

376 Health Policy and Politics

377 Population Policy and Politics

400 Advanced Political Topics

442 International Peacekeeping and Conflict Resolution

443 International Politics of Climate Change

478 Seminar in International Studies

496 Undergraduate Seminar

 PSY Psychology

374 Cross Cultural Psychology

RELG-Religious Studies

333  Ritual Symbols and Behavior

SOC-Sociology

306  Peace and Conflict

312  Causes of Crime and Delinquency

398  Special Topics in Sociology

415 Inequality and Power

452  Community Organizing and the Struggle for Justice in America Peace Studies

461 Visualizing Global Change

SUST-Sustainability

402 Topics in Sustainability Studies

*Here is a PDF of the upper division ELECTIVES for BALA

90,000 Experts assessed Ukraine’s chances of creating a UAV capable of destroying a Russian tank

In Ukraine, videos, photos have been presented, and technological characteristics of the ACE ONE multipurpose attack unmanned aerial vehicle have been published. Simulated footage of the presentation showed how a Ukrainian UAV is destroying a Russian T-90 tank and a Russian Orion drone. However, as experts interviewed by Gazeta.Ru note, there is an abyss from a video clip to the appearance of a flight model, not to mention a serial product.

What the Ukrainians have shown

The official presentation of the ambitious project will take place at the Arms and Security-2021 exhibition.

Judging by the advertising video, the ACE ONE unmanned aerial vehicle is equipped with an AI-322F bypass turbojet engine. This engine is a modification of the experienced AI-222K-25F and has a maximum thrust of 4200 kg. In addition, in Zaporozhye, in AI-322F, a complete Ukrainian localization of all components was carried out (before that the “cold” part of the AI-222K-25 / K-25F engine was produced in cooperation with the Russian Gas Turbine Research Center “Salyut”).

This allows, with very significant dimensions of the ACE ONE UAV (length – 8 meters, wingspan – 11 meters) and weight (maximum takeoff weight – 7.5 tons), to develop almost the speed of sound, that is, M – 0.95.

At the same time, according to the calculations of Ukrainian designers, the strike UAV will have a combat range of 1,500 km and rise to an altitude of 13.5 km.

As conceived by the designers, the Ukrainian unmanned strike vehicle will not be just a reconnaissance vehicle, but will be able to carry and use high-precision guided weapons and free-fall bombs against both ground and air targets.

So, in the video presented by the Ukrainian side, ACE ONE destroys an unmanned vehicle similar to the new Russian reconnaissance and strike UAV “Orion” with a missile, and in another frame it hits the Russian T-90 tank with another UAV missile.The bombing of a small military camp with free-fall bombs was also demonstrated.

“Judging by the video released by the Ukrainian developers for the exhibition, the new UAV is proposed to be used not only against stationary and mobile ground targets, but also against air targets, which conceptually distinguishes this project from existing counterparts working on objects on the surface,” noted in a conversation with Gazeta.Ru, editor-in-chief of the Unmanned Aviation magazine Denis Fedutinov.

Where the wings grow from

At the presentation of the project, the audience was informed: “25 best Ukrainian scientists and specialists in the field of the aerospace industry” worked on the implementation of this idea, headed by the former General Director of Antonov State Enterprise Alexander Los and the former head of the State Space Agency of Ukraine ) Vladimir Usov.

Ukrainian developers claim that UAVs were developed by the best enterprises in Ukraine, such as SE Ivchenko-Progress, JSC Motor Sich and LLC Gidrobest – the leading enterprises in Eastern Europe in the production of gas turbine engines and aircraft components.

Judging by the video, the ACE ONE UAV has many similarities with the American project Lockheed Martin RQ-170 Sentinel and the Russian C-70 Okhotnik.

Denis Fedutinov sees another parallel in the Ukrainian project.In a conversation with Gazeta.Ru, the expert expressed the opinion that the ACE ONE apparatus in its outlines rather resembles the X-47B UAV developed by the American company Northrop Grumman than other drones. It is also a “tailless” – the air intake of the turbojet engine is located in the upper part, the weapon is hidden in the internal compartments.

“At the same time, the promising Ukrainian drone is significantly inferior in terms of weight and dimensions to the aforementioned American vehicle, as well as to the Russian UAV“ Okhotnik ”.So, the maximum take-off weight of ACE ONE is 2.5 times less than the mass of the X-47B and, probably, 3 times less than that of the “Okhotnik”, – explained Fedutinov.

The preliminary cost of one complex of several aircraft (probably three) and a ground control station is $ 12-13 million – the Ukrainian developer indicated this price in an English-language press release.

Will this work?

Analyzing the presentation of ACE ONE, the Ukrainian edition of Defense Express comes to the conclusion that in this case we are talking about the creation of a multifunctional combat aircraft that is capable of using various types of modern and advanced heavy weapons against targets both on the ground and in the air and performing functions inherent in combat aircraft (for example, F-16A or Dassault Rafale).

Russian experts are more restrained in assessing the presentation. In their opinion, the project of Ukrainian developers is not suitable for anything except for high-profile headlines in the media.

“The Ukrainian side has fulfilled its task: cheaply raised a wave of hyperhype in the media space. However, specialists understand that there is no scientific and technical groundwork and industrial base for the implementation of such a project in Ukraine. Computer models and exhibition models do not replace science and industry, ”explained Gazeta.Ru ”editor-in-chief of the magazine“ Arsenal of the Fatherland ”Viktor Murakhovsky.

According to the expert, the creation of a heavy attack jet UAV capable of acting autonomously or in the same formation with manned aircraft (the concept of Loyal Wingman – “faithful wingman”) is a difficult task. It has not yet been fully resolved even by the leading military powers – the USA, Russia, the PRC.

“The main problem is not in a glider made using stealth technology, not in a jet engine, but in autonomous control systems for high flight speeds, artificial intelligence technologies for interacting with other aircraft, making decisions based on an independent assessment of the situation” considers Victor Murakhovsky.

“So far there is no guarantee that the T-90 tank, drawn by Ukrainian designers in a commercial, will be perceived by artificial intelligence as a target.

But there is a nonzero probability that “own” artificial intelligence will aim ammunition at the main battle tank of the T-64 APU. But Ukrainian advertisers don’t bother with this, ”emphasizes the editor-in-chief of the magazine“ Arsenal Otechestva ”.

Denis Fedutinov from “Unmanned Aviation” also believes that the sensationalism of the appearance of this kind of development in Ukraine should not be overestimated – from the layout and the cinema to the appearance of a flying model, not to mention a serial product, there is an abyss.

According to Fedutinov, the developers are trying to make a “hype” on a fashionable theme, maximizing the impression by combining unique functionality and at the same time low cost. However, it is obvious that even if they can find funding for the implementation of this project, its terms and financial costs will differ several times from those figures that are presented today with a rather dubious final result.

“It should be noted that Ukraine currently has no implemented projects in the field of UAV systems of any serious dimension. All unmanned systems created and operated by the troops belong to the small class. Projects of the tactical UAV Gorlitsa from the Antonov Design Bureau, the Sokol-300 medium-altitude long-duration UAV from the Luch State Design Bureau, as well as some other previously announced projects have not been implemented, “Fedutinov noted.

According to the expert, the lack of implemented projects excludes the possibility of using the developments.Many subsystems in the field of navigation and control systems, reconnaissance and surveillance, etc., necessary for the creation of such an apparatus, are simply not available in Ukraine. Engineers and designers will have to build them from scratch. Such problems are typical for countries trying to develop new areas of competence.

“This process could be simplified by international cooperation with leading technologically developed countries. However, the prospects that they will share their developments in such a sensitive area are rather dubious, ”concluded Denis Fedutinov.

90,000 as a new Russian interceptor drone can change the fight against enemy UAVs – RT in Russian

Russian specialists have completed flight tests of an upgraded version of the newest Wolf-18 interceptor drone. This was reported by the Almaz-Antey concern. The UAV is capable of automatically searching for enemy vehicles. Enemy drones are disabled by special trap nets. After firing the charges, the operator can direct the “Wolf-18” to the ram.According to experts, such a weapon is a very effective and economical means of dealing with small-sized UAVs at short distances.

Flight tests of the improved unmanned drone hunter “Wolf-18” have been completed in Russia.

“Flight tests of the upgraded version of” Wolf-18 “, which included the actual destruction of target drones, have been successfully completed. The drone has been significantly improved. We plan to enter state tests this year, “RIA Novosti quotes a representative of Almaz-Antey.

The press service of the concern confirmed this information to RT.

Testing the capabilities of the “Wolf-18” made it possible to establish that the UAV-interceptor is capable of detecting small enemy vehicles in a fully automatic mode and effectively disabling them.

“Insidious weapon”

“Wolf-18” was first demonstrated to the general public at the international military-technical forum “Army-2019”. The upgraded version is presented at the National Exhibition and Forum of Civil Aviation Infrastructure NAIS 2021, which is taking place these days in Moscow at the Crocus Expo.

The drone is a joint brainchild of specialists from Almaz-Antey and other domestic enterprises. This is the first product of this class in Russia.

Also on the topic

Striking technique: what tasks can Russian kamikaze drones perform?

Kamikaze drones will join the arsenal of the Russian tracked combat robot Marker. This was announced by the Deputy Head of the Fund …

The interceptor drone is a quadcopter with dimensions of 60 x 60 cm and a take-off weight of 6 kg.The modified version of the “Wolf-18” is equipped with a new optical-location station, providing an increased target detection range, as well as an improved control system, which made it possible to automate its work.

The drone maneuvers independently, searches for and selects enemy objects. The operator confirms the decision to destroy targets. “Wolf-18” approaches the target and shoots a net at it.

As a result, the attacked drone begins to lose altitude and crashes on the ground.The interceptor drone is armed with three mesh launchers. When these charges run out, the soldier who operates the UAV can use the ramming function.

The flight time of “Wolf-18” is relatively short – 30 minutes. Therefore, the military must launch it into an area where enemy drones are already located.

According to experts, the creation of the “Wolf-18” is dictated by the desire of the military and gunsmiths to simplify and reduce the cost of detecting and intercepting small-sized UAVs, including devices of handicraft production of illegal armed formations (IAF).

• Unmanned aerial vehicles involved in the attack on Russian military facilities in Syria
• RIA News
• © Ministry of Defense of the Russian Federation

According to the Ministry of Defense of the Russian Federation, such drones, despite their apparent simplicity, pose a serious threat due to the modern electronic and technical stuffing.Small terrorist vehicles can carry out single and massive strikes in automatic mode, dropping ammunition carried on board.

Russia faced the danger of using drones by members of illegal armed groups in Syria. Over the past years, terrorists in Idlib have regularly launched UAVs to attack the Russian Khmeimim airbase. To repel an attack by drones, Russian military personnel use electronic warfare (EW) and air defense systems, in particular the Pantsir-S1 anti-aircraft missile and cannon system.

Despite the successes of the RF Armed Forces in the fight against enemy vehicles, traditional weapons are not always highly effective, and their operation is sometimes quite expensive, said in an interview with RT a researcher at the Diplomatic Academy of the RF Ministry of Foreign Affairs, director of the PIR Center’s program on new technologies and international security Vadim Kozyulin.

Also on the topic

“Disorganize unmanned aircraft flights”: what new methods of fighting UAVs are being mastered by the Russian army

The servicemen of the Central Military District have successfully practiced repelling the attack of small-sized low-flying UAVs of a simulated enemy…

“Homemade small drones are insidious weapons. Their cost is low, and they create a lot of problems. They are difficult to detect by radar stations due to their low reflectivity, and optics do not always cope. And the shooting is sometimes carried out with expensive anti-aircraft missiles, ”said Kozyulin.

According to the expert, it makes sense for Russia and other states to adopt new means of defense against UAVs, including those adapted to countering drones in an urban environment.He recalled that earlier great hopes were pinned on laser and electromagnetic systems, but there is no significant progress in their improvement so far.

The American army is also puzzled by the neutralization of threats emanating from small-sized vehicles. In January of this year, it became known that the US Air Force Research Laboratory plans to announce a tender for the development of a device capable of countering such UAVs.

“These capabilities are intended to combat small unmanned aerial vehicles available on the wide commercial market and other means based on similar technologies, which are currently used by our opponents in asymmetric combat operations against military personnel, as well as weapons and property of the US Armed Forces.” , – says in the preliminary description of the contract.

Police drone

In a conversation with RT, the editor of the newspaper “Nezavisimoye Voennoye Obozreniye” Dmitry Litovkin noted that the advantage of the “Wolf-18” is its reusability. Such a product, as the expert believes, will be effective when it is necessary to eliminate the threat from one or more UAVs.

“I think that such a device will mostly perform police functions, that is, intercept individual small devices.The Wolf-18 is not suitable for dealing with a swarm of drones, but, in my opinion, the Derivation self-propelled complex with inexpensive artillery ammunition will cope well with this task, ”says Litovkin.

According to the expert, it makes sense for Russia to create interceptor drones, but they are unlikely to be able to reduce the importance of traditional air defense systems in the fight against drones.

“The main application of the” Wolf-18 “, in my opinion, will be to prevent unauthorized filming of objects subject to protection and to combat the launch of unmanned aerial vehicles that are not registered and not registered anywhere,” Litovkin suggested.

• Interceptor drone “Wolf-18”
• © Concern VKO “Almaz-Antey”

This view of the specialization of “Wolf-18” is shared by the military expert Yuri Lyamin. In an interview with RT, he called the newest domestic drone a promising means of neutralizing the danger posed by multicopters – small vehicles that are now massively used for reconnaissance and sabotage.

Wolf-18 is faster than conventional copters. Accordingly, he can catch up with them, use mesh launchers or ram. This is a promising thing, but it will be widely used, most likely, for anti-terrorist purposes and in urban areas, where fire on drones can cause panic among the civilian population, ”Lyamin explained.

According to the expert, domestic designers have found an original and safe solution by equipping the “Wolf-18” with mesh launchers.

“If this UAV manages to get by with nets alone, then it will generally be a very cheap way to deal with unwanted drones.In addition, “Wolf-18” is a mobile system – it is easy to transport, deploy and launch in the desired location. Other systems are larger and take longer to deploy, ”Lyamin summed up.

Kia unveils new logo and global brand slogan, symbolizing bold transformation for the future

January 6, 2021

Kia Motors Corporation today unveiled its new logo and global brand motto, marking a bold step towards transformation and a new global goal.The introduction of the new logo expresses Kia’s commitment to becoming a leader in the future mobility industry. For this, almost all areas of the company’s business will be transformed.

The logo symbolizes Kia’s new brand ambition and the values ​​it promises to offer customers through future products, services, and related experiences. Kia seals its promise with a new logo that resembles a handwritten signature. The logo’s rhythmic, unbroken line symbolizes Kia’s commitment to creating inspirational moments for customers in any brand interaction, and its symmetry demonstrates brand confidence.The rising lines of the new logo embody the brand’s growing ambition and, more importantly, what it offers to customers.

“The new Kia logo reflects the company’s commitment to change and innovation,” said Ho Sung Song, President and CEO of Kia. “The automotive industry is undergoing an era of rapid transformation, and Kia strives to be at the forefront of change, adapting to these changes. The new logo symbolizes our desire to inspire customers as their needs for mobility evolve and our people to meet the challenges of a rapidly changing industry. ”

The new logo was unveiled during a record-breaking pyrotechnic show overlooking Incheon, South Korea. The show featured 303 “pyrotechnic drones” that simultaneously unleashed hundreds of fireworks in artistic performance, celebrating Kia’s new initiative and symbolically launching a new era for the company. This number of specialized unmanned aerial vehicles has become a new world record in the Guinness Book: “The largest number of UAVs to simultaneously launch fireworks.”The awesome show can be seen on Kia’s global YouTube channel.

New global brand goal and strategy will be unveiled on 15 January 2021

In addition to a completely redesigned logo, Kia has also unveiled a new global brand slogan, Movement that inspires. Details of Kia’s new strategy – in particular the brand’s mission and philosophy, and how this will translate into Kia’s future lineup – will be unveiled at the New Kia Brand Showcase online.It will take place on Friday, January 15 at 03:00 Moscow time (9:00 AM South Korea time). The broadcast will be available on Kia’s global YouTube channel.

The Kia logo update is a continuation of Plan S’s 2020 long-term development strategy. As part of Plan S, among other targets, Kia announced its intentions to become one of the leaders in the global car market. It is planned to achieve this goal by concentrating efforts on the popularization of electric vehicles and the provision of a wide range of mobility services, which would be tailored as accurately as possible in accordance with the needs of each client and the specifics of each market.

The strategy for the introduction of the new Kia logo in the territories covered by Kia Motors Russia and the CIS, as well as other changes, will be announced later.

LADA dealer in Blagoveshchensk

LADA Vesta: 5th anniversary of the flagship

September 25 marks 5 years since the start of production of LADA Vesta cars. Created in partnership with the Renault-Nissan Alliance, Vesta has become a new significant step in the development of the entire LADA brand. The new model quickly became one of the leaders of the domestic market, constantly improving and winning the love of Russians.New style LADALADA Vesta is the first production car based on the X-style DNA. For the first time presented to the public at the Moscow International Motor Show in 2014, LADA Vesta received so many good reviews that the production car practically does not differ from the conceptual layout. And the new face of LADA is broadcast on other brand new items. The image of LADA Vesta is emotional, bright and 100% recognizable. Vesta also received a new brand logo in the form of a rook, which noticeably increased in size and became voluminous.It was very important for the creators of LADA to propose such an evolutionary approach, given that the car design language became a revolution for the LADA brand itself. Development of LADA Vesta LADA Vesta received a number of technical solutions that were then used on LADA cars for the first time, for example, stability control systems (ESC) and ERA-GLONASS is already in the basic configuration. Moreover, LADA Vesta has become one of the safest in its segment, gaining the maximum 4 “stars” according to the results of the ARCAP crash test. LADA Vesta was not adapted for Russia, it was made for Russia, taking into account all the real needs of potential customers.This approach has been implemented in new features such as rear disc brakes, heated rear seats and a steering wheel, a lockable gas hatch, and electric folding mirrors. The car also received larger wheels, new soundproofing elements and new safety options. Also, Vesta compares favorably with its competitors with high ground clearance and impeccable handling. One of the most recent and significant innovations: in 2019, a continuously variable automatic transmission from the Japanese company Jatco appeared on cars.Over the course of 5 years, LADA Vesta has transformed into a whole family of cars: a cross-version was added to the base sedan, as well as stylish and practical SW and SW Cross, dual-fuel Vesta CNG, “charged” LADA Vesta Sport. Sport: from debut to leadership Even before the start of sales LADA Vesta entered sports tracks, taking part in the WTCC World Touring Car Championship. Racing sedans in the new “X-design” LADA not only attracted public attention, but also achieved 12 podiums at various stages of the championship. Today LADA cars are leading in the Russian racing series, and since 2017 the pilots of the LADA Sport ROSNEFT team have been successfully performing in specially prepared LADA Vesta in the Touring and Super Production classes.Recognition of experts and customers For five years, LADA Vesta has changed a lot, retaining all its key advantages and receiving new functions in accordance with market trends and customer requirements. Being the flagship model, it always keeps up with the times and is highly appreciated by industry experts and customers. The model has received many awards, including 5 awards “Car of the Year in Russia” and 5 awards “Golden Pegasus” according to the results of the Grand Prix of the magazine “Behind the wheel.” start of production.At the same time, according to a survey of buyers, every third person switched to LADA Vesta from a car of a different brand. At the end of 2018, Vesta became an absolute Russian bestseller, and today it confidently ranks second in terms of sales after LADA Granta. To date, more than 450 thousand LADA Vesta of all modifications have been sold. Additional information: JSC “Amur-Lada” is the official dealer of LADA in the Amur region. The AVTOVAZ group is a part of the Renault-Nissan-Mitsubishi Alliance and produces full-cycle cars for 4 brands: LADA, Renault, Nissan, Datsun.The Group’s production facilities are located in Togliatti – AVTOVAZ JSC and in Izhevsk – LADA Izhevsk LLC. The LADA brand is represented in the B, B +, SUV and LCV segments, which comprise 5 model families: Vesta, XRAY, Largus , Granta and 4×4. The brand occupies 20% of the Russian passenger car market. The official dealer network of the Brand is the largest in Russia – more than 300 dealer centers.

Kalashnikov has created a new unique UAV

ZALA Aero, a member of the Kalashnikov concern, has developed a unique unmanned aerial vehicle (UAV).According to the concern, the new drone is capable of broadcasting a video stream in HD format (1280 * 720).

Photo: topwar.ru

This allows the operator to view the streaming video in great detail. “The new unmanned complex ZALA 421-16EV HD is distinguished by a unique adaptive system for using the aerodynamic properties of UAVs in all flight modes,” the Kalashnikov concern said.

The advantage of the model lies in the possibility of vertical take-off and landing, which is carried out completely in automatic mode.As for the reliability of the model, duplicate security systems are responsible for this. Before being put into mass production, the complex passed two types of tests: in the factory and in the field.

“The BVS ZALA 421-16EV model has almost limitless possibilities and provides a huge potential for monitoring and aerial photography of any hard-to-reach places and areal objects,” Kalashnikov emphasizes.

“Kalashnikov” has created an attack UAV that will change the face of war

And last year the concern presented another unique drone – a small-sized “Cube-UAV”.The American edition of The Washington Post even wrote about this: “The Russian company, which presented the world with the famous AK-47 assault rifle, presented an attack drone. It could similarly revolutionize warfare by making modern unmanned aerial vehicle technology available and inexpensive. ”

The newspaper quotes the words of the professor of international relations at the University of Illinois, Nicholas Grossman.He believes that drone buyers will be able to “control the bomb with a high degree of accuracy, unparalleled except for some of the smartest bombs in the US military.”

One of the representatives of the concern told the publication that the new device will be “very cheap” in contrast to American and Israeli attack drones. However, he declined to name its cost, noting only that the target market would be “smaller armies” around the world.

“Cube-UAV” was presented to the public at the International Arms Exhibition IDEX 2019.According to the presentation, the flight speed of the device is up to 80-130 km / h, depending on the load. At the same time, the duration of the work is 30 minutes, the maximum payload is 3 kg, the dimensions are 1210x950x165 mm.

After launch, the drone can loit in the air, detecting a target, and then attacks it from the upper hemisphere, having the ability to dive at the target along a vertical trajectory. This makes it possible, for example, to hit tanks on the battlefield from the side of the upper hemisphere, piercing the tower, which has minimal armor in the upper part.

Conventional air defense systems will experience great difficulties when trying to counter the concern’s new high-precision unmanned aerial vehicle, Rostec head Sergei Chemezov said earlier. He added that this complex is a step towards a completely new conduct of hostilities. : ///

Analyst: Turkey’s new military drone will not replace modern

fighters

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Best of its kind: Turkish TB2 drones featured in Netflix spy series

Armed drones produced by Turkey’s domestic defense industry have become more sophisticated in execution, but will not be able to cover the country’s military needs without buying a new generation of fighters in the next decade, analyst Paul Iddon said.

Unmanned aerial vehicles (UAVs) are suitable for warfare, in which Turkey is usually involved, such as guerrilla tactics used by the outlawed Kurdistan Workers’ Party (PKK), or the operation of Turkey and its supported militia in Syria against government forces. for Forbes.

The use of UAVs is also a way for the Turkish military to compensate for the country’s suspension from the US F-35 fighter program in connection with its acquisition of Russian S-400 missile defense systems last year, Iddon said.

He emphasizes that Turkey is developing its own fifth generation TAI TF-X fighter, but it is unlikely to enter service in the next decade. Meanwhile, the stock of old F-16 and F-4 aircraft in Turkey needs to be replaced, the author points out.

He recalls that Baykar Defense’s armed Bayraktar Akıncı drone has a wingspan of almost 20 m and can fly at an altitude of 12.2 km. It can fly for 24 hours without recharging and has a flight range of over 482 km.

Baykar Defense, owned by relatives of Turkish President Recep Tayyip Erdogan’s Bayraktar family, announced the completion of high-altitude tests of an armed drone last week, Iddon writes.

The author adds that the drone will be equipped with Ukrainian-made engines, alternative domestic engines, intelligent micro-ammunition and general-purpose bombs. It will be able to launch short-range air-to-air missiles, as well as long-range Turkish-made som cruise missiles.Its electronically scanned radars, electronic warfare, wide area surveillance and satellite communications systems are being developed locally.

According to security expert Metin Gyurkan, Akıncı will be used as the main vehicle of the Turkish army to observe and detect targets, the article says.

However, the Jamestown Foundation analysis showed that the drone “can be very effective in detecting and destroying individual ground targets, such as enemy howitzers or mortars, or special equipment such as electronic warfare stations.”

According to the author, with the help of Akıncı and a number of other internal projects, Turkey has significantly reduced its dependence on allies.

Regional Forest Fire Service received a new unmanned aerial vehicle

Regional Forest Fire Service received a new unmanned aerial vehicle

https://www.admin-smolensk.ru/novosti/news/news_18596-html/

2017-11-02 04:41:06

In accordance with the instructions of the Governor Alexey Ostrovsky, for the needs of the Forest Fire Service of the Smolensk Region, quadrocopter Phantom 4 Pro + ( Plus ) was purchased, season 2018.

The new drone will complement the work of the other unmanned aerial vehicle Zala 421-08, which will create additional opportunities for aerial fire reconnaissance. Employees of the Forest Fire Service are already testing it.

In accordance with the instructions of the Governor Alexey Ostrovsky, for the needs of the Forest Fire Service of the Smolensk Region, quadrocopter Phantom 4 Pro + ( Plus ) was purchased, season 2018.

The new drone will complement the work of the other unmanned aerial vehicle Zala 421-08, which will create additional opportunities for aerial fire reconnaissance. Employees of the Forest Fire Service are already testing it.

Speaking about the technical characteristics of the new quadrocopter, it is worth noting that its flight time is 30 minutes at an altitude of 500 meters. The maximum range is 4 thousand meters. The drone is capable of speeds up to 72 km / h. Preparation of the device for operation takes only a few minutes, which makes it very convenient to use.

Aerial monitoring of the forest fire situation is one of the main activities of the regional Forest Fire Service. In particular, aerial reconnaissance allows not only detecting forest fires at an early stage and assessing their scale, but also identifying potential fire hazardous areas of forest areas, in particular, windblows, windbreaks and dead woods. On the basis of the data obtained in the course of aerial monitoring, workers of fire and chemical stations, forestry departments and tenants of forest areas organize their further work to prevent forest fires and limit their spread.