ARTICLES BY NANCY BRADISH MYERS
-
FDA User Fee Programs Reauthorized: FDA's CBER Is A Clear Winner10/6/2022
Last 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.
-
Marks Took On FDA Vaccine Leadership Position – What Happens Now?11/2/2021
Center 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.