by rss feed | Jul 30, 2025 | FDA, News Feeds, Politics, Prasad Tidmarsh, Vinay Prasad departure
Vinay Prasad is out at the FDA after less than three months. It may be the shortest tenure as CBER Director in FDA history. This is an ominous sign for the agency, but probably not just for the reasons you might first think. Vinay Prasad’s departure and gaps in...
by rss feed | Jul 16, 2025 | FDA, FDA understaffed, News Feeds
Marty Makary’s FDA appears to be struggling on several fronts. It’s not surprising but comes with big risks for the agency and country. Think of the departures of Peter Marks, Nicole Verdun, Celia Witten, and many others like staff scientists, physicians,...
by rss feed | Jun 19, 2025 | FDA, News Feeds, Nicole Verdun
Someone at the FDA has placed Nicole Verdun, the Super Director of The Office of Therapeutic Products at the agency, and her deputy, Rachael Anatol, on administrative leave as of yesterday. The agency continues to shed key, experienced leadership, most of the...
by rss feed | Jun 5, 2025 | FDA, FDA Cell & Gene Therapy Roundtable, News Feeds, parachute trials
I had high expectations when I saw the list of speakers for an FDA Cell & Gene Therapy Roundtable held today. Admittedly, earlier when I had seen the meeting announced and no speakers were listed, I wondered how it might go. Would it be like the earlier RFK Jr....
by rss feed | Apr 22, 2025 | CBER, FDA, News Feeds, Trump biotech
The Trump Administration just quickly gutted the FDA including key leadership. What is going to be the impact of this sudden purge? Former Commissioner Robert Califf recently said it is the end of the FDA as we’ve known it. Those are dramatic words, but they...
by rss feed | Apr 8, 2025 | FDA, News Feeds, Tracy Beth Høeg, Tracy Hoeg
New FDA Commissioner Marty Makary has brought on Dr. Tracy Beth Hoeg (or Høeg) as a special assistant. Hoeg has had some controversial views on COVID. She has seemed skeptical of certain elements of vaccination, masking, and school closing. What struck me is that she...
