FDA posts a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment" to help applicants with designing and managi...
Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency that they were no longer marketed.
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Section 564 Declared E...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Federal Register notice: FDA makes available a veterinary-use draft guidance entitled #290 (VICH GL61) Pharmaceutical Development.
