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  1. accessiblemeds.orgGenerics & Biosimilars | Association for Accessible Medicines

    21 de mai. de 2024 · Join us in celebrating Dr. Janet Woodcock’s remarkable 38-year career at the U.S. FDA. As a trailblazer in drug regulation, she has shaped the pharmaceutical landscape and left an enduring legacy. Presented by Women in Health Policy (WiHP) and powered by AAM, this special session will explore her visionary leadership and achievements.

  2. jamanetwork.com › journals › jamaCombined Vaccines Against COVID-19, Flu, and Other ...

    17 de mai. de 2024 · JAMA Medical News. Editorial. May 2024 Medical News Summary. 0:00. As the number of vaccines for adults grows, manufacturers have begun working on combining some of them into a single injection. However, whether combination vaccines for adults are at least equal to—or even greater than—the sum of their parts has yet to be proven.

  3. www.biocentury.com › article › 652564ssssssssssssssDebating a new pathway for ultrarare

    Há 4 dias · Former Acting FDA Commissioner Janet Woodcock proposed the creation of a new approval pathway for therapies when it is impossible to conduct trials required to meet standard requirements. Woodcock sparked much of the controversy over regulatory flexibility in 2016 by overruling FDA staff and approving Exondys 51 eteplirsen from Sarepta Therapeutics Inc. (NASDAQ:SRPT) for Duchenne muscular ...

  4. www.biocentury.com › article › 652531BioCentury - ASCO preview, rare diseases & Biogen M&A: a ...

    29 de mai. de 2024 · The editors also discuss interest by Janet Woodcock, former director of FDA’s Center for Drug Evaluation and Research, in a new approval pathway for ultrarare therapies, the Foundation for the National Institutes of Health’s initiative to support development of therapies and diagnostics for amyotrophic lateral sclerosis (ALS ...

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  6. endpts.com › fdas-marks-woodcock-talk-regulatoryFDA’s Marks, Woodcock talk regulatory flexibility for new ...

    22 de mai. de 2024 · The FDA’s top bi­o­log­ics chief and a for­mer deputy com­mis­sion­er on Tues­day dis­cussed the need for reg­u­la­to­ry flex­i­bil­i­ty for rare dis­ease ther­a­pies and un ...

  7. www.packgene.com › frontier › 240528FDA details new 'platform technology' process that could ...

    28 de mai. de 2024 · In a recent discussion, Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, and Janet Woodcock, former FDA deputy commissioner, highlighted the critical need for regulatory flexibility in developing rare disease therapies.

  8. finance.yahoo.com › news › milken-instituteMilken Institute Announces Key Initiatives at the 2024 Global ...

    7 de mai. de 2024 · Prevention and Innovation - Project Prevent. The Milken Institute recognizes that societies around the world are under strain from demographic changes, evolving disease patterns, and rising health...