Study finds unintended consequences of FDA initiative requiring manufacturers of unapproved drugs to obtain approval or remove them from the market but FDA says study does not consider broad impact of the initiative.
FDA's strategy for dealing with drugs marketed before the 1962 law requiring them to be proven efficacious may have led to an increase in drug prices and shortages, according to a study led by Yale University School of Medicine alumnus Ravi Gupta.
The researchers examined products that fell under FDA's 2006 Unapproved Drugs Initiative (UDI), which requires manufacturers of unapproved drugs to...
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.
