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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...
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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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    FDA Updates COA Compendium for First Time Since 2016

    As part of the US Food and Drug Administration’s (FDA) efforts to encourage more patient-focused drug development, the agency on Wednesday released an updated Clinical Outcome Assessment (COA) Compendium as a resource on a variety of different diseases and conditions. The compendium, which has been updated for the first time as part of an extension to a pilot COA Compendium that was launched in January 2016, can help companies understand how certain COAs have been used ...
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    FDA Warns Chinese OTC Drug Manufacturer for Falsifying Documents

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research earlier this month sent a warning letter to China-based sunscreen and OTC drug manufacturer NingBo Huize Commodity Co. after the company’s general manager and quality manager admitted that multiple documents provided to FDA were falsified “for the purpose of this inspection.” FDA placed the firm on import alert in June and said that the firm agreed to recall all drug products distributed...
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    CDER Plots Pilot Project to Test CDISC Standard

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday said it will conduct a small pilot project to test the processing and analysis of nonclinical study data provided electronically using an updated standard, known as the SEND 3.1, from the Clinical Data Interchange Standards Consortium (CDISC). CDER is seeking a maximum of five participants for the pilot, which will evaluate the compliance of sample SEND 3.1 datasets subm...
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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...