ARTICLES BY NANCY BRADISH MYERS

• FDA User Fee Programs Reauthorized: FDA's CBER Is A Clear Winner

  10/6/2022

  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.

• Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise

  5/5/2021

  With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.