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    Industry lauds PDUFA VII focus on innovation, transparency

    Trade associations in the pharmaceutical and biotechnology fields have weighed in on the performance goals FDA has outlined for the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA VII), taking a generally favorable view of planned initiatives and areas of focus.   “The PDUFA VII agreement released today is an important step forward to continue to support patient safety, maintain the FDA’s high standards of independent regulatory review and promote...
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    Woodcock calls for investigation into Aduhelm approval

    The US Food and Drug Administration’s acting head has called on the Inspector General at the Department of Health and Human Services to conduct an investigation into matters related to the agency’s recent controversial approval of Biogen’s new Alzheimer’s disease drug Aduhelm (aducanumab).   Janet Woodcock, acting director of the US Food and Drug Administration (FDA), took to Twitter early Friday afternoon to make the announcement, sharing the letter she sent to Christ...
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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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    FDA releases batch of 21 product-specific guidances

    The US Food and Drug Administration (FDA) on Wednesday issued 13 new and eight revised draft product-specific guidances intended to facilitate the development of generic drugs.   The guidances are intended to foster generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug (RLD). FDA’s current count of product-specific guidances sits at 1,896 with this latest release....
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    FDA finalizes QIDP Q&A guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on its qualified infectious disease product (QIDP) designation program.   The 12-page guidance finalizes a draft version released for comment in 2018 and includes a revised question and answer section providing clarification on the types of products the agency considers to be antibacterial or antifungal drugs for the purposes of the designation. (RELATED: FDA Drafts Q&A Guidance on QIDP Designati...
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    FDA welcomes alternative approaches to generic drug development

    Issuance of a product specific guidance should not “diminish innovation or creativity” in generic drug development, Robert Lionberger, director for the office of research and standards in the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Generic Drugs, said at a 5 May webinar on the development of product specific guidance.   FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of G...
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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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    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) this week issued 36 new and revised draft product-specific guidances meant to facilitate the development of generic drugs by clarifying the agency’s expectations for the studies required to demonstrate bioequivalence (BE) to a reference listed drug (RLD).   The latest batch of guidances includes 22 new and 14 revised draft guidances covering drugs to treat prostate cancer, hepatitis C, multiple sclerosis and numerous other cond...
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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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    FDA unveils plans to tackle COVID variants

    The US Food and Drug Administration (FDA) on Monday unveiled recommendations for vaccine, drug and diagnostic test developers to address the impact of COVID-19 variants on the efficacy and performance of their products.   The recommendations are made across four new and updated guidances targeting vaccines , drugs and biologics , monoclonal antibodies and diagnostic tests .   “The purpose of these guidances is to address the emergence and potential future emer...