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    Cavazzoni paints CDER's post-pandemic future

    During an hour-long session at the annual meeting of the Food and Drug Law Institute (FDLI), the director of FDA’s Center for Drug Evaluation and Research (FDA’s CDER) went beyond a recap of the prior year’s challenges and wins, looking ahead to what CDER’s post-pandemic future will look like.   Summing up what she termed the “gestalt of the last 18 months,” CDER Director Patrizia Cavazzoni highlighted progress and trends in staffing, drug development and inspections t...
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    COVID test EUAs updated with pooled serial testing option

    The US Food and Drug Administration (FDA) has taken steps to make it easier to pool test samples for many molecular diagnostic tests for SAR-CoV-2, the virus that causes COVID-19.   The agency’s amendment to many test emergency use authorizations (EUAs) now allows sample pooling to screen asymptomatic individuals when the testing is performed at least once weekly as part of a screening strategy.   “Pooling, the process of combining multiple specimens together to mo...
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    Cavazzoni named to permanent CDER director role

    Patrizia Cavazzoni, MD, has been named director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER).   The appointment, announced on Twitter Monday morning, comes after Cavazzoni spent the past year as acting director of CDER. She was appointed to the position when Janet Woodcock, MD, left to assume her role leading the therapeutics arm of the COVID-19 accelerator Operation Warp Speed (OWS).   “Pleased to announce the perma...
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    CDER missing more BsUFA target dates amid pandemic

    The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) faced a mountain of work and logistic challenges during the COVID-19 pandemic. While the agency met most of its user fee goals, its performance in moving original biosimilar applications along fell short of the pace it kept in other areas.   A new report from CDER tracks how well the agency fared in acting on applications by type and by quarter, looking at the last two quarters o...
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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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    2020 Drug Safety: CDER spotlights COVID-19 activities, nitrosamine contamination

    COVID-19 was a big safety focus in 2020 for the US Food and Drug Administration (FDA), from the evaluation of drugs for emergency use authorization (EUA) to surveillance for critical drug shortages and medical product supply chain disruptions. The 2020 Drug Safety Priorities report from the FDA’s Center for Drug Evaluation and Research (CDER) chronicles a busy year in safety monitoring and enforcement, including COVID-related activities, nitrosamine impurities, and re...
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    CDRH officials dissect early-pandemic test guidance missteps

    A guidance permitting use of certain COVID-19 antibody tests had downstream negative consequences that the US Food and Drug Administration (FDA) did not envision when the document was issued nearly a year ago, including inappropriate use of the tests and an influx of tests based on falsified data or marketed with false claims.   In a New England Journal of Medicine editorial, two senior FDA officials laid out the agency’s experience with COVID-19 antibody tests, high...
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    CDER lays out 2021 guidance agenda

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released a list of the new and revised draft guidances it plans to release in 2021.   The agenda, while oftentimes aspirational, provides insights as to what the agency’s drug center’s new guidance priorities are for the coming year. However, the list does not include draft or revised guidances the agency plans to finalize in 2021. (RELATED: 2020 CDER draft and revised guidance...
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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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    Top CDER officials discuss budget priorities, staffing and COVID

    With negotiations underway for the next iterations of the US Food and Drug Administration’s (FDA) new and generic drug user fee programs, top officials from the Center for Drug Evaluation and Research (CDER) discussed budget and staffing priorities in a call with the Alliance for a Stronger FDA on Friday.   Budget priorities   “We have really made major strides thanks to Congress’ support in the appropriations that we received in 2019, in investing in modernizing t...
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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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    OND Reorganization Moves Forward

    The US Food and Drug Administration said Thursday that the planned reorganization of its Office of New Drugs (OND) will move forward thanks to Congressional approval, including changes to its Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ). The changes will create offices for interrelated disease areas and divisions with clearer and more focused expertise, FDA said , noting the number of OND offices that oversee its review division...