RE:RE:RE:Pancreatic surgeon Dr. Marty Makary appointed head of FDA... neither Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), nor [ Jefferies] analysts anticipate major changes to the FDA’s oversight of therapeutics. “We do not see fundamental impacts to the Agency’s stance on the majority of biotech innovation (non-vaccines) and especially to key areas of unmet need including rare and orphan diseases, oncology, inflammation/autoimmune, and others,” Jefferies wrote.
"Marks similarly noted that he does not anticipate changes to the regulation of other drug classes overseen by CBER, including gene and cell therapies, and given that uptake of the COVID vaccines is already low, any potential impact of the new administration on vaccine usage will likely be limited."
https://www.biospace.com/policy/trumps-team-of-self-promoters-will-make-for-great-reality-tv-but-an-uncertain-biopharma-environment