[ Price : $8.95]
A new CDRH Web page on tips for providing stakeholder comments on guidance documents says the Center prefers comments that are sub...[ Price : $8.95]
FDA clears a CathVision 510(k) for the PVI Analyzer and Signal Complexity algorithms as part of the companys electrophysiology rec...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion warns AstraZeneca that a sales aid for its Breztri misrepresents the drugs efficacy...[ Price : $8.95]
FDA publishes a guidance on the roles of IRBs, clinical investigators, sponsors, and FDA in informed consent for clinical investig...[ Price : $8.95]
FDA warns Boston, MA-based TEI Biosciences about Quality System violations in its manufacturing of collagen-based products.[ Price : $8.95]
FDA removes a partial clinical hold against an Arcellx IND for CART-ddBCMA, an investigational drug for treating patients with rel...[ Price : $8.95]
FDA approves Delcath Systems Hepzato Kit (melphalan for injection/hepatic delivery system) for liver-directed treatment in adult p...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection revision entitled Biologics License Applications (BLAs) Proced...