FDA Review posts the Federal Register notices for the week ending 2/3/2017.
Based on positive data, Janssen Research & Development says it has stopped early a Phase 3 trial (COMPASS) that was evaluating the efficacy and safety...
After 10 years at FDA, deputy director for personalized medicine Elizabeth Mansfield is leaving the agency next week to join cancer screening start-up...
FDA clears a Biolase 510(k) for its fifth-generation Waterlase Express all-tissue laser system for use in dental procedures.
Vice president Mike Pence swears in Rep. Tom Price (R-GA) as HHS secretary after being confirmed overnight (52 to 47) following a series of grueling S...
Sen. Chuck Grassley (R-IA) says he is gathering information on possible misuses of the orphan drug program and how that might affect drug prices.
A just-filed citizen petition asks FDA to determine whether the 180-day marketing exclusivity for a Handa ANDA for quetiapine fumerate extended-releas...