ARTICLES BY NANCY BRADISH MYERS
-
![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.
-
![FDA-Scott-Gottlieb]( "Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb's Exit")
Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb's Exit3/7/2019It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many, from investors to parents of teens tempted to vape. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.
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.