The CDER Office of Prescription Drug Promotion warns AstraZeneca that a sales aid for its Breztri misrepresents the drugs efficacy.
FDA publishes a guidance on the roles of IRBs, clinical investigators, sponsors, and FDA in informed consent for clinical investigations.
FDA warns Boston, MA-based TEI Biosciences about Quality System violations in its manufacturing of collagen-based products.
FDA removes a partial clinical hold against an Arcellx IND for CART-ddBCMA, an investigational drug for treating patients with relapsed or refractory ...
FDA approves Delcath Systems Hepzato Kit (melphalan for injection/hepatic delivery system) for liver-directed treatment in adult patients with uveal m...
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.
