Federal Register notice: FDA makes available a final guidance entitled Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.
FDA clears an EnsoData 510(k) for new capabilities and enhancements to its EnsoSleep product, an artificial intelligence-assisted sleep scoring progra...
Innoveix Pharmaceuticals recalls several lots of sterile compounded drug products due to a lack of sterility assurance that was determined by a recent...
Federal Register notice: FDA announces that it has issued a priority review voucher to Mallinckrodts Stratatech unit after approving its material thre...
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Labeling Regulations.
FDA approves a new warning on Johnson & Johnsons Covid-19 vaccine about the risk of Guillain Barr syndrome.
Two House committees request documents from Biogen about its controversial Alzheimers drug approval.
An FDA briefing document asks members of the Cardiovascular and Renal Drugs Advisory Committee to consider potential safety risks with FibroGens roxad...