Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Section 564 Declared E...
FDA clears a ZygoFix 510(k) for its zLOCK Lumbar Facet Fixation System an implant that adapts to the joint's anatomy during insertion to offer increas...
FDA clears a Phonak 510(k) for its Phonak Lyric hearing aid and a self-replacement option to reduce office visits.
Federal Register notice: FDA issues an order permanently debarring Adam Paul Runsdorf over his felony conviction for conspiring to distribute counterf...
CDER launches a new Quantitative Medicine Center of Excellence to help streamline and accelerate drug development.
Federal Register notice: FDA makes available a veterinary-use draft guidance entitled #290 (VICH GL61) Pharmaceutical Development.
An unusually strident Wall Street Journal editorial apologizes to its readers for supporting FDA commissioner Robert Califfs appointment now that hes ...
Regeneron faces a potential approval delay on its supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patien...
