FDA makes available a guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.
Federal Register notice: FDA classifies the fluid jet system for prostate tissue removal into Class 2 (special controls).
Federal Register notice: FDA makes available a draft guidance entitled Coronary, Peripheral, and Neurovascular Guidewires Performance Tests and Recom...
FDA posts an ICH guidance entitled S9 Nonclinical Evaluation for Anticancer Pharmaceuticals: Questions and Answers.
Federal Register notice: FDA makes available a draft guidance entitled Intravascular Catheters, Wires, and Delivery Systems with Lubricious CoatingsLa...
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.