FDA releases the FDA-483 with three observations issued following an inspection at a Lupin API manufacturing facility.
Federal Register notice: FDA submits to OMB an information collection extension for electronic drug product reporting for drug compounding outsourcing...
Federal Register notice: FDA makes available a final guidance entitled Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings-L...
FDA says its scientists have found a way to improve influenza candidate vaccine viruses.
FDA clears a Sky Medical Technology 510(k) for its geko device for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patien...
FDA releases a dashboard to help view data on Biosimilar User Fee Act performance metrics.
Federal Register notice: FDA makes available a final guidance on coronary, peripheral, and neurovascular guidewire testing and labeling.
Federal Register notice: FDA makes available a final guidance entitled Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission...