Connecticut attorney general William Tong leads a 44-state lawsuit against Teva Pharmaceuticals and 19 generic drug manufacturers that alleges a broad...
FDA approves Abiomeds expanded use of its Impella 5.0 and Impella LD heart pumps for treating cardiogenic shock.
FDA Review posts the product approval summaries for the week ending 5/10/2019.
FDA Review posts product approval summaries for the week ending 5/10/2019.
Federal Register notice: FDA makes available a guidance entitled Determining Whether to Submit an ANDA or a 505(b)(2) Application.
Federal Register notice: FDA makes available a final guidance entitled Maximal Usage Trials for Topically Applied Active Ingredients Being Considered ...
FDA posts a final guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product to help sponsors navigate the pathway ...
The quality of the U.S. drug supply is the best it has ever been, according to CDER director of pharmaceutical quality Michael Kopcha, responding to a...