FDA classifies as Class 1 a Roche Diagnostics recall of its CoaguChek XS PT Test Strips due to inaccurate International Normalized Ratio test results.
FDA approves an Aquestive Therapeutics NDA for Sympazan (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut s...
Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee vote 21 to 2 that the benefit-r...
FDA posts a guidance on Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices...
Federal Register notice: FDA makes available a draft guidance entitled Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.
Federal Register notice: FDA announces a 12/6 public workshop entitled Product Development in Hemophilia.
FDA approves an AcelRx Pharmaceuticals resubmitted NDA for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-severe acute ...