Federal Register notice: FDA makes available a draft guidance entitled 510(k) Third-Party Review Program.
FDA approves a Biotronik humanitarian device exemption for its PK Papyrus Covered Coronary Stent System which is intended to treat acute coronary arte...
FDA approves a Sun Pharmaceutical Industries NDA for Xelpros (latanoprost ophthalmic emulsion) 0.005% for reducing elevated intraocular pressure in pa...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that recommend bioequivalence study designs...
Pharmaceutical Manufacturing Research Services files (XXX SPACE XXX)a lawsuit against FDA in eastern PA federal court seeking an order to compel the a...
Federal Register notice: FDA makes available a final guidance entitled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for M...
FDA issues a safety alert on Alcons CyPass Micro-Stent, a small tube with tiny holes that is surgically implanted in the eye, due to its risk of eye d...
FDA announces steps to streamline its use of medical device third party reviewers.