Weekly reads: Prasad exit & replacement, FDA on Leucovorin, Mexico’s stem cell clinic industry
Professor Paul Knoepfler, Ph.D.
Vinay Prasad is leaving the FDA again in a few weeks. As CBER Director, Prasad was all over the place on how he handled oversight of biologics. He and Commissioner Marty Makary promised flexibility from the agency, but so far we’ve mostly just seen chaos. Some like The WSJ felt that Prasad’s decisions were overly strict and inflexible. However, what got me was the chaos and potential role of politics in biologics decisions. Some of that stems from Makary and RFK Jr. and won’t change with...