ARTICLES BY NANCY BRADISH MYERS
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![FDA headquarter iStock-1213293784]( "FDA User Fee Programs Reauthorized: FDA's CBER Is A Clear Winner")
FDA User Fee Programs Reauthorized: FDA's CBER Is A Clear Winner10/6/2022Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.
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![FDA headquarter iStock-1213293784]( "Marks Took On FDA Vaccine Leadership Position – What Happens Now?")
Marks Took On FDA Vaccine Leadership Position – What Happens Now?11/2/2021Center for Biologics Evaluation and Research Director Dr. Peter Marks decided to temporarily take on the leadership of the Office of Vaccine Research and Review after both its director, Marion Gruber, and deputy director, Philip Krause, unexpectedly announced in late August their decisions to exit the FDA.
Nancy Bradish Myers
Nancy Bradish Myers, JD, president of Catalyst Healthcare Consulting, Inc., is a Washington, D.C.-based attorney with deep expertise in healthcare law and regulation, policy development, patient engagement, and government relations. She served as senior policy counsel in the Office of the FDA Commissioner, as well as special assistant/senior strategic advisor to the FDA acting deputy commissioner for operations. Myers has been closely involved in drug, biotechnology, and medtech regulatory issues for over 25 years. She currently advises clients on regulatory and health policy matters. You can reach her at nancy@catalysthcc.com or connect with her on LinkedIn.