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    FDA issues guidance on resuming or initiating BE studies amid pandemic

    New guidance from the US Food and Drug Administration (FDA) issued on Friday provides recommendations for resuming or initiating bioequivalence (BE) studies for generic drugs during the COVID-19 pandemic.   The guidance, aimed at ensuring participant and study staff safety, calls on generic drug developers to carefully consider protocols for resuming or initiating BE studies and to take steps to ensure the scientific validity of data generated from studies impacted by ...
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    PREPP initiative: FDA’s COVID-19 response and the path forward

    The US Food and Drug Administration (FDA) has adapted in its response to the COVID-19 pandemic, from increasing transparency of its risk-benefit analyses for emergency use authorizations (EUAs) to providing guidance on vaccine development, according to a summary report of the agency’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative.   The report catalogues the agency’s work during the pandemic, noting that it has published and revised more than 65...
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    FDA sped progress for most of 2020's novel drugs

    Most novel drugs approved by the US Food and Drug Administration (FDA) in 2020 made their way through the approvals process using one or more expedited approval pathways, and over half of sponsors received the incentives that accompany orphan drug designation, according to an FDA report detailing the year’s approvals.   Novel drug approvals continued at a brisk clip, averaging over one per week in 2020. Despite the pandemic the 53 novel drugs approved in 2020 bested 20...
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    FDA issues potency testing guidance for COVID antibody treatments

    Amid the coronavirus pandemic, the US Food and Drug Administration has issued guidance on potency assays for manufacturers of monoclonal antibodies and other therapeutic proteins to treat COVID-19. The guidance is immediately effective for the duration of the public health emergency.   In the ordinary course of business, FDA would have engagement with drug developers to work on potency assays “over a span of years.” However, according to the guidance, “given the compre...
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    In 2020, all goal dates met for CDER's novel approvals

        Editor’s note: come back to Regulatory Focus tomorrow for an expanded examination of these approvals, including which sponsors made use of expedited programs, and which programs were used most frequently.   A slate of 53 drugs makes up the list of novel drugs approved by the US Food and Drug Administration in 2020. The list, released Wednesday, includes such notables as Veklury (remdesivir, Gilead), a shelved antiviral repurposed to treat COVID-19 infection,...
  • Industry, FDA begin to hammer out PDUFA VII details

    Discussions continue between industry and the US Food and Drug Administration (FDA) regarding the upcoming reauthorization of user fees for prescription drugs, biologics and generic drugs. After public hearing and a first round of meetings that gave a peek into priorities for industry and regulator representatives, this next round began to sort out some detail. (RELATED: PDUFA VII: FDA and industry set priorities in first round of negotiations , Regulatory Focus 29 Octo...
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    HHS pushes through last-minute policies impacting FDA

    With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that could impact the US Food and Drug Administration’s (FDA) regulatory oversight.   Last week, HHS announced it had finalized a rule that would cause its regulations to expire if they are not reviewed every 10 years, with some exceptions provided for medical device-specific regulations, food standards and over-the-cou...
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    Updated: FDA’s top lawyer resigns

    Editor's note: This article has been updated to reflect clarification from HHS about who will fill the role of chief counsel. The US Food and Drug Administration’s (FDA) top lawyer, Chief Counsel Stacy Cline Amin, resigned from the agency, effective Monday, according to an email to agency staff from FDA Commissioner Stephen Hahn.   However, the announcement as to who would succeed Cline Amin was met with confusion as the Department of Health and Human Services (HH...
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    Hahn offers advice to incoming Biden administration

    With the transition to a new administration less than two weeks away, US Food and Drug Administration (FDA) Commissioner Stephen Hahn on Friday told reporters at an Alliance for Health Policy briefing that he has offered his help to the incoming administration but does not expect to stay on as commissioner.   “I have had the opportunity to talk to transition team and I have certainly offered my willingness to help after the transition in any way that they see fit,” Hah...
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    FDA lays out 2021 regulatory science areas of focus

    Three strategic initiatives form the backbone of the regulatory science areas of focus for the US Food and Drug Administration in 2021, according to a new report.   The Focus Areas of Regulatory Science (FARS) issued on Monday “outlines topics that the FDA has identified as needing continued targeted investment in regulatory science research to facilitate the development of innovative products, provide data and methodology to inform regulatory decision-making and impro...
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    CDER reorganization continues with new offices and divisions

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Friday detailed plans to reorganize five of its offices this year.   In an email to staff, Acting CDER Director Patricia Cavazzoni said the approved structural changes in the Office of Generic Drugs (OGD), Office of Strategic Programs (OSP), Office of Surveillance and Epidemiology (OSE), Office of Management and Office of Compliance “will enable us to respond to new priorities...
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    What happened with FDA’s OTC monograph user fee notice?

    Just before the New Year, the US Food and Drug Administration (FDA) published a notice in the Federal Register announcing the fee rates it will collect for its Over-the-Counter (OTC) Monograph Drug user fee program (OMUFA) in FY2021, as it did earlier in the year for its other user fee programs.   The seemingly innocuous act proved controversial for its potential impact on liquor distillers who stepped in to manufacture hand sanitizers amid the COVID-19 pandemic an...