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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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    FDA outlines process for communicating record requests findings

    The US Food and Drug Administration (FDA) says it has put in place an interim process to communicate issues identified during record reviews done in lieu of or in advance of preapproval inspections with drugmakers and consider their responses before taking action on an application.   The agency says the interim process will continue throughout the COVID-19 public health emergency and may be extended to other drug inspection programs, including routine surveillance insp...
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    Inspections: GAO calls on FDA to plan for backlog, review alternatives

    In a nearly 350-page report to Congress on the federal government’s COVID-19 response, the Government Accountability Office (GAO) calls on the US Food and Drug Administration (FDA) to review its inspections approach and come up with a plan to address its looming backlog.   Pandemic inspection alternatives   In the early days of the pandemic, FDA halted non-mission-critical foreign and domestic inspections and relied on alternative tools, such as inspection reports ...
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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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    FDA details review timelines as facility assessment-related CRLs pile up

    In guidance released Monday, the US Food and Drug Administration (FDA) provides the timelines it will stick to when reviewing responses to complete response letters (CRLs) for drugs and biologics when a facility assessment or inspection is required in order for the agency to make a decision on the application.   FDA’s ability to conduct on-site inspections has been dramatically curtailed amid the COVID-19 pandemic due to public health concerns and travel restrictions. ...
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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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    FDA issues pandemic inspections FAQ guidance

    The US Food and Drug Administration (FDA) on Wednesday issued an immediately effective frequently asked questions guidance  explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic.   Inspections   For the time being, FDA says it is still following the approach to resuming domestic inspections it laid out last month and will continue to postpone non-mission-critical foreign pre-approval an...
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    FDA looks to resume domestic inspections this month

    Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Friday said it plans to resume on-site domestic inspections beginning the week of 20 July 2020.   As a safety measure, FDA will pre-announce all inspections, save for retail tobacco inspections, for the foreseeable future.   The announcement comes nearly two months after the agency said it will implement a phased approach to restartin...
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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 ...