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...
Three stakeholders give technical suggestions to change an FDA draft guidance on data integrity for in vivo bioavailability and bioequivalence studies...
Federal Register notice: FDA issues an order debarring Michael Terry Little for five years from importing or offering for import any drug into the U.S...
