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June 09, 2020

Health Law Daily

FDA May Delay Processing Of Applications That Don’t Address COVID-19 By A Month Or Two

  • June 09, 2020

Bloomberg Law (6/8, Baumann, Subscription Publication) reports the COVID-19 pandemic may delay “the FDA’s ability to advance applications for potentially transformative cell and gene therapy treatments, the head of the biologics center’s advanced therapies office said.” The agency “may have to push back meetings for applications that don’t address Covid-19 by a month or two.,” and “agency reviewers...may also have to submit written responses instead of holding teleconferences as they otherwise would have, Wilson Bryan, director of the Office of Tissues and Advanced Therapies in the FDA Center for Biologics Evaluation and Research, said Monday at BIO Digital, the first virtual international convention by the Biotechnology Innovation Organization.”