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.

• 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.

• FDA Shutdown: Assessing The Potential Impact On Innovation And Public Health

  1/11/2019

  I am not an expert on immigration or building walls. I don’t pretend that I can totally understand the political strategy of either party at the high level of the government shutdown. But as someone very familiar with the FDA, I am growing increasingly concerned that the longer the government shutdown continues — dragging the FDA along with it — the greater the potential for harm to the public health.

• Trump's Deregulatory Agenda: What It Could Mean For Biopharma & Medtech Companies

  4/20/2017

  Within just a few days of taking office, President Trump launched his deregulatory agenda, and he has now issued several executive orders that build on each other. This article analyzes the executive orders and the Office of Management and Budget’s implementation guidance to agencies — and offers insights on their implications for the FDA and innovators.

• 21st Century Cures & FDA Implementation: 5 Important Takeaways For Biopharma Companies

  12/21/2016

  Now that the 21^st Century Cures bill has been signed into law — following a nearly three- year journey that included a fair number of detours and roadblocks — all eyes in the drug development world are shifting to FDA.  To the question “What now?”  FDA can answer: A great deal of work.

• 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.