Federal Register notice: FDA sends to OMB an information collection revision entitled Biologics License Applications (BLAs) Procedures and Requirement...
Federal Register notice: FDA seeks comments on an information collection extension entitled Registration of Human Drug Compounding Outsourcing Facilit...
FDA denies a St. Jude Childrens Research Hospital request to allow some use of codeine-containing analgesics in patients under age 12.
FDA commissioner Robert Califf says dietary supplement risk management will be elevated with the integration of the Office of Dietary Supplement Progr...
Oncopeptides says it is going to file a formal appeal of FDAs recent request for the company to voluntarily withdraw its accelerated-approved multiple...
FDA sets 2/22/2024 as the PDUFA action date for its priority review of Venatorx Pharmaceuticals NDA for cefepime-taniborbactam to treat complicated ur...
FDA grants AngioDynamics a breakthrough device designation for its AngioVac System and its proposed indication for use to include the non-surgical rem...
Federal Register notice: FDA debars Ildiko M. Knoll for five years from importing or offering for import any drug into the U.S.
