Day: April 24, 2025

The Prescription Drug User Fee Act (PDUFA), enacted in 1992, has transformed the U.S. drug approval process by providing the FDA with essential funding from biopharmaceutical companies. Critics often argue that this funding creates conflicts of interest, claiming it “corrupts” the FDA. One such narrative is presented in another book published this week, which misrepresents … Read more

Clinical trials with high-risk medical devices frequently involve historical controls and other criteria as concurrent control groups in such studies are not feasible or ethical. A survey of about 100 high-risk medical devices approved by the FDA over five years shows some interesting trends in using non-concurrent controls in medical device trials. Between 2019 and … Read more