FDA chief unveils new office for drug reviews

FDA Commissioner Scott Gottlieb will tell the biotech bigwigs at the J.P. Morgan Healthcare Conference in San Francisco today how the agency plans to modernize the review of drug applications. The new Office of Drug Evaluation Science will be tasked with creating a standard way to include personalized medicine and digital data in those reviews. Gottlieb will be beamed in for the talk, though — he canceled plans to go to the Bay Area to help the FDA’s limited staff navigate the continuing partial government shutdown.

Meanwhile, seven former FDA commissioners are calling for the agencyto become independent from HHS, which, the commissioners argue, would free it from political whims.