FDA cautions against using unapproved products that claim to clean CPAP machines and accessories with ozone gas or UV light.
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Federal Register notice: FDA makes available a draft guidance entitled Product Labeling for Laparoscopic Power Morcellators.
Federal Register notice: FDA makes available a final guidance entitled Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) W...