FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.
Gritstone Bio reports mixed data from an ongoing Phase 2 portion of a Phase 2/3 study evaluating Granite, a personalized neoantigen cancer vaccine for...
Eli Lilly says any revision of an FDA guidance on weight management drugs should incorporate a modern scientific characterization of obesity as a chro...
A report by Spotlight on America suggests FDA is increasing scrutiny over CooperSurgical and its manufacturing facility in North Tonawanda, NY, where ...
FDA posts a guidance entitled FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Bio...
Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance on Oxymetazoline Hydrochloride.
CDER Office of Surveillance and Epidemiology director Gerald J. Dal Pan says FDA is developing new tools to help identify drug postmarket safety issue...
FDA clears a Baxter International 510(k) clearance for its Novum IQ large volume infusion pump with Dose IQ safety software.
