Federal Register notice: FDA determines the regulatory review period for Auspex Pharmaceuticalss Austedo (deutetrabenazine), indicated for treating ch...
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...
Federal Register notice: FDA makes available a final guidance entitled Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommenda...