FDA publishes a draft guidance on processes and practices for Bioresearch Monitoring inspections.
A January FDA inspection at Jiangsu Hengrui Pharmaceuticals in Jiangsu, China, leads to an eight-observation Form FDA-483 that cites significant GMP d...
Federal Register notice: FDA withdraws 23 NDAs from multiple applicants after being notified by the application holders that the products were no long...
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Recall Authority 21 CFR Part 810.
FDA commissioner Robert Califf and two colleagues make the case for so-called pragmatic clinical research using real-world evidence.
Bristol Myers Squibb reports favorable data from a Phase 3 trial evaluating the dual immunotherapy combination of Opdivo (nivolumab) plus Yervoy (ipil...
FDA warns Mississauga, Canada-based Techlem Medical Corporation about Quality System violations in its manufacture of misbranded wheeled stretchers.
Arrow International recalls (Class 1) its Arrow FiberOptix Intra-Aortic Balloon Catheter Kit after receiving reports about infrequent device malfuncti...
