FDA Reviews Precision Drugs Faster, With Less Evidence Than Other Drugs

Academic researchers found FDA has approved precision medicines 1.7 years faster on average than nonprecision medicine and with substantially less premarket evidence, which they cautioned could expose patients to unknown risks and uncertain benefits. While the decreased review time speeds up marketing and lowers development costs, it also necessitates waiting for years to collect postmarket data to glean potential adverse events, the researchers concluded in a May Health Affair s article. FDA has approved a handful of drugs in the...