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.

• 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.

• Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb's Exit

  3/7/2019

  It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23^rd 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. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.

• Trump And The FDA: What to Expect (And What's At Stake)

  11/22/2016

  Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.