Federal Register notice: FDA announces the user fee rates for fiscal year 2023 for medical devices.
Three Hyman, Phelps & McNamara attorneys say several recent drug approvals appear to signal a new FDA interest in using confirmatory evidence despite ...
Merck exercises an option to collaborate with Moderna on a personalized cancer vaccine currently being evaluated in a Phase 2 trial.
Jiangsu Well Biotech (Jiang Su Sheng, China) recalls its Covid-19 Ag Rapid Test Devices because they were distributed without authorization, clearance...
FDA says CDRH is launching the Total Product Life Cycle Advisory Program (TAP) pilot program called for in the MDUFA 5 reauthorization agreement.
FDA warns Earth City, MO-based Legacy Pharmaceutical Packaging about CGMP violations and insanitary conditions in its manufacturing of finished drugs.
FDA extends the deadline for comments on a draft guidance intended to improve labeling for LASIK devices used in vision correction.
The Washington DC District Court rules against FDA in granting summary judgment to plaintiff Melinta Therapeutics that suspends the approval of a gene...
