FDA hosts a 10/15-16 public workshop to convene a discussion on methodological approaches that may be used to develop and identify what is most import...
House Republicans derail a Trump-supported legislative measure that would have required drug companies to include prices in their direct-to-consumer a...
Federal Register notice: FDA announces an 11/28 public workshop entitled Pathogen Reduction Technologies for Blood Safety.
FDA Review posts the Federal Register notices for the week ending 9/14/2018.
Federal Register notice: FDA makes available a draft guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards.
Federal Register notice: FDA makes available a draft guidance entitled 510(k) Third-Party Review Program.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...