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...
FDA says hand sanitizer produced by Chinas Guangzhou Minghui Cosmetics Co. is an unapproved new drug that is adulterated and misbranded.
CDERs Heather Stone describes improvements made to CURE ID to make it possible to track repurposed Covid-19 drugs more easily.
Just-released minutes describe industrys overall proposal for the MDUFA 5 agreement.