FDA approves an Acacia Pharma Group NDA for Barhemsys (amisulpride injection) for preventing and treating postoperative nausea and vomiting (PONV) in ...
HHS deputy inspector general Suzanne Murrin tells House Appropriations Committee members there are steps FDA can take to reduce medical device risks a...
Two Hyman, Phelps attorneys see a troubling pattern in deadlines being missed by CDRH.
FDA commissioner Stephen Hahn says media reports are wrong about the agency monitoring 150 prescription drugs that could be in short supply if plants ...
Mark McClellan and Ellen Sigal suggest four steps for FDA to take to move into the 2020s.
FDA warns LeeSar about violations in its work producing drugs as an outsourcing facility.
Federal Register notice: FDA makes available a final guidance entitled Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.
Federal Register notice: FDA makes available a draft guidance entitled Product Labeling for Laparoscopic Power Morcellators.