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    CBER sets strategic priorities through 2025

    Facilitating product development, conducting research, boosting preparedness against health threats and organizational excellence top the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) strategic goals for the next five years.   Those goals are detailed in CBER’s 42-page strategic plan, released Wednesday, and account for new legislation and scientific advances since the center’s previous interim plan for FY2017-2019. That le...
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    PDUFA VII negotiations continue as industry presses for clear timelines

    As meetings continue between the US Food and Drug Administration (FDA) and industry to negotiate the upcoming reauthorization of the Prescription Drug User Fee Amendments (PDUFA VII), cell and gene therapy demands and timelines continue to loom large. Minutes from this and other end-of-year PDUFA subgroup meetings continue to show how industry and FDA are working to balance commitments and resources for PDUFA VII.   In a 17 December 2020 breakout meeting, representativ...
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    Updated: FDA issues EUA for J&J's one-shot COVID vaccine

    The US Food and Drug Administration (FDA) has issued an emergency use authorization for the COVID-19 vaccine developed by Janssen, a division of Johnson & Johnson. “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, MD in a statement announcing ...
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    FDA updates EUA guidance, addressing vaccines against COVID variants

    The US Food and Drug Administration (FDA) has revised its guidance for developers of vaccines against COVID-19 as regulators and health authorities assess the need to adjust vaccines so they remain effective as new SARS-CoV-2 variants emerge.   For the time being, developers can expect to conduct immunogenicity studies for vaccines to address these variants that will enroll “on the order of few hundred individuals in terms of size,” said Peter Marks, MD, PhD, director ...
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    CBER lays out scaled-down guidance agenda for 2021

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released its list of draft and final guidances it plans to issue in 2021.   The list contains just 14 guidances, half of which will be draft documents, down from 31 guidances in 2020 and 20 guidances in 2019. Of those 14 guidances, only a few are new additions to the list, with the remainder being carried over from the previous year.   CBER was able to cross more tha...
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    Marks fields questions on cell and gene therapy development

    Expect new guidance from the US Food and Drug Administration (FDA) on the manufacture of CAR-T cells, said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER).   Marks answered questions on a range of issues related to cell and gene therapy development during a webinar hosted by Genetic Engineering & Biotechnology News .   Saying that CBER is working on new guidelines for CAR T-cell therapy manufacturing, Marks said, “The agen...
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    CBER withdraws 20 draft and final guidances

    Last week, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) withdrew 20 draft and final guidances, more than half of which date back to the 1980s and 1990s.   Many of the withdrawn guidances relate to blood and blood products, donor screening and HIV. Among the guidances are a Y2K-era guidance on handling the year 2000 date change for computer systems and software applications used to manufacture blood products and a 200...
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    Is FDA Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss

    From industry to academia, commenters have argued that the US Food and Drug Administration’s (FDA) drug approval standards are becoming inappropriately low and that the required postapproval evaluations are either inadequate or left undone. But three senior FDA officials offered several counterpoints on Monday at the fifth annual Biopharma Congress in Washington, DC. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained that the agency ...
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    As the Race for a Permanent FDA Commissioner Picks Up, Agency Turnover Continues

    With a decision on a permanent US Food and Drug Administration (FDA) Commissioner slated for the end of October at the latest, the steady stream of FDA employee defections to industry continues. So, who will be nominated as the next commissioner? Some influential health groups and former FDA commissioners (including Scott Gottlieb), according to the Washington Post , are pushing for Acting Commissioner Ned Sharpless to be nominated, while the Wall Street Journal...
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    As Stem Cell Clinics Proliferate, E&C Leaders Seek to Hear FDA’s Plan

    A bipartisan group of representatives on the Energy & Commerce (E&C) committee sent a letter to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless on Thursday seeking more details on the agency’s plan to slow the proliferation of stem cell clinics. While noting that FDA has agreed to exercise enforcement discretion for 36 months in a recent guidance, the letter also explains how CBER Director Peter Marks said in April that industry has shown “mo...
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    Two Gene Therapy Approvals Headline CBER’s FY 2018 Report

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Wednesday published its Fiscal Year 2018 report, highlighting two gene therapy approvals, as well as the approvals of a hepatitis B vaccine, a vaccine to prevent shingles and a flu vaccine for children as young as six months. Both of the gene therapy approvals occurred at the very beginning of the previous fiscal year, with CBER signing off on Spark Therapeutics’ Luxturna...
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    CDER Looks Ahead at Real World Evidence

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Friday held a webinar reviewing the agency’s real-world evidence (RWE) framework, which deals primarily in the postmarket space for drugs and biologics. The agency  unveiled  its RWE framework last December to provide a high-level view of how it is looking at the use of real-world data. Jacqueline Corrigan-Curay, director of the Office of Medical Policy within CDER, explaine...