Commissioner expresses concern about agency lawyers leaving and then representing US FDA’s opponents in court. Also, as lawsuits about abortion pill continue, KFF finds the public trusts FDA more than the judiciary on determining products’ safety and effectiveness.
Welcome to another edition of Supplemental Filings, where US-based Pink Sheet reporters offer bonus, quick-hit analysis and insight we think you should know about, but didn’t make it into full-length stories.
Commissioner Robert Califf continues to raise attention about what he terms the “revolving door for lawyers,” between the FDA and...
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.
As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.
Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.
