Federal Register notice: FDA withdraws approval of two Ferring Pharmaceuticals ANDAs because the company notified the agency that they were no longer ...
FDA approves Medtronics 200mm and 250mm lengths of its In.Pact Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions in patient...
FDA posts a guidance on Logical Observation Identifiers Names and Codes for In Vitro Diagnostic (IVD) Tests.
Public Citizen praises the Senate Judiciary Committee for reporting out a bill to stop innovator drug companies from using the regulatory system to ke...
FDA advisors vote 11-4 to recommend that the agency approve Cordis Incraft stent-graft device for use with abdominal aortic aneurysms.
FDA issues a draft guidance to help sponsors develop systemic drug products for HIV-1 pre-exposure prophylaxis.
FDA says distributors of drug products containing isometheptene, considered to be unapproved new drugs, agreed to cease distribution as of 1/1.
FDA issues a draft guidance on information to be included in labeling for PMAs or 510(k)s for devices containing lubricious coatings used in the vascu...