• Regulatory NewsRegulatory News

    In advance of adcomm, Pfizer makes its case for Comirnaty booster

    In briefing documents made available on Wednesday in advance of a US Food and Drug Administration (FDA) meeting, Pfizer made the case that a third dose of its COVID-19 vaccine would address an unmet public health need in the face of high and persistent levels of Delta variant breakthrough infections among the vaccinated.   Pfizer’s application for a supplemental biologics license application (sBLA) for Comirnaty, the messenger RNA (mRNA) COVID-19 vaccine it co-develope...
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    TrackersTrackers

    FDA Advisory Committee Calendar

    Regulatory Focus is pleased to team with Tarius , a regulatory information services provider, to routinely offer information about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner. Upcoming Meetings   13 September – Allergenic Products Advisory Committee   The committee will discuss and make recommendations on the safety and efficacy of Peanut [Arachis hypogaea] Allergen Powder manufactured by Ai...
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    FDA Advisory Committee Recommends Amgen-UCB Osteoporosis Drug

    With a final vote of 18-1, the bone, reproductive and urologic drugs advisory committee (BRUDAC) wrapped up a hearing on Wednesday with a recommendation that the US Food and Drug Administration (FDA) approve Amgen and UCB’s Evenity (romosozumab) osteoporosis treatment. The BRUDAC hearing on Wednesday marked Amgen and UCB’s second review for Evenity. The new recommendation comes after FDA issued a Complete Response Letter in July 2017 for the Biologics License Applicat...
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    Preparing for an FDA Advisory Committee Approval Meeting

    This article discusses the nuances of FDA Advisory Committee approval meetings and provides an interpretive overview of what regulatory professionals need to know to prepare for a meeting. Introduction The US Food and Drug Administration (FDA) define an Advisory Committee simply as a group of external experts convened to offer advice to the agency. However, in realty, the practice is more complicated. In other places on its website, FDA states Advisory Committees can ...
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    FDA Seeks Industry Representation on 17 of its Drug Advisory Committees

    • 15 April 2015
    The US Food and Drug Administration (FDA) is reaching out to the pharmaceutical and biopharmaceutical industries for input on which industry experts should serve on 18 of its influential advisory committees. Background FDA's advisory committees are comprised of experts—approximately 8-17 of them per committee—which make recommendations to FDA on matters of policy and specific products. For example, a committee might recommend a specific product be approved because of it...
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    What you Need to Know About Meeting With FDA's Medical Device Advisory Committee

    For many medical device companies, a meeting with a US Food and Drug Administration (FDA) Advisory Committee is a high-profile, high-stress event. A successful meeting can assure regulators, patients and investors that a product is safe and effective, while an unsuccessful meeting can torpedo a product's chances at a timely approval. Background Now FDA is out with a new guidance document which aims to help medical device companies navigate the confusing lead-up process...
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    Updated: FDA Disbands Advisory Committee in Charge of Review of HIV, AIDS Drugs

    The US Food and Drug Administration (FDA) has disbanded its Antiviral Drugs Advisory Committee, a committee charged with the review of products intended to treat HIV and AIDS, and transferred its authority to an existing advisory committee with a new name, the agency announced this week. In a 19 March 2015 posting in the Federal Register , the government's daily record of agency actions, FDA said it was immediately disbanding the committee as it "is no longer needed." ...
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    Conflicts of Interest on FDA's Advisory Committees Don't Matter Much, Paper Finds

    Conflicts of interest among members of the US Food and Drug Administration's (FDA) influential advisory committees don't have much of a practical impact on the outcome of voting decisions, new research argues. Background The paper comes as several research papers in recent years have made the opposite case—that advisory committee members with stated conflicts of interest do affect how a committee makes a decision. For example, a September 2014 paper in the journ...
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    FDA Appoints Members to New, Influential Advisory Committee

    Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector. Background The re-creation of the PCAC was called for under the Drug Quality and Security Act (DQSA) , which sought to update the way in which FDA regulated p...
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    FDA Announces a Secretive Meeting to Discuss an Unknown Drug for Unknown Reasons

    The US Food and Drug Administration (FDA) regularly convenes panels of its various Advisory Committees to offer the agency advice on a wide range of regulatory topics—everything from general policy recommendations to specific advice on a particular drug or drug class. In general, those panels—and the advice they dispense—is open to the public. For example, per 21 CFR 314.430(d) , most drug products being assessed by FDA's advisory committees are open to the public and a...
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    After Intense Scrutiny, FDA Set to Take Another Look at OTC Antiseptics

    The US Food and Drug Administration (FDA) will soon hold a meeting regarding the safety and efficacy of non-prescription antiseptic products, just months after raising concerns about the products to manufacturers. Background OTC topical antiseptics are generally used to prepare a site prior to injection to reduce the chance of site infection. While some of the products are currently distributed in single-use form, many are packaged in multiple-use packages like tubes th...
  • Meet BRUDAC, FDA's Old Committee With a New Name and Charge

    The US Food and Drug Administration (FDA) has announced that its Advisory Committee for Reproductive Health Drugs (ACRHD) will, effectively immediately, be getting a name change. Under a new charter announced on 10 April 2014, the committee will see its name changed to the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC), better reflecting its current scope of responsibilities, FDA said. The new committee will review and evaluate data on human drug prod...