Federal Register notice: FDA makes available a final guidance entitled Long Term Follow-Up After Administration of Human Gene Therapy Products.
FDA issues a Warning Letter to Smart Toothpicks (Tempe, AZ) after the agency determined that its dissolvable tobacco products, Peppermint Ice Nicotine...
Federal Register notice: FDA makes available a draft guidance on recommendations to reduce the possible risk of transmission of Creutzfeldt-Jakob Dise...
FDA clears an Olympus 510(k) for the TJF-Q190V duodenoscope with a sterile, disposable distal endcap for enhanced reprocessing.
In his first address to FDA employees, FDA commissioner Stephen Hahn says unleashing the power of data will be a key objective while he is at the agen...
FDA says that Medtronic has released the first round of software updates to address some cybersecurity vulnerabilities identified in wireless telemetr...
FDA approves Aimmune Therapeutics Palforzia [peanut (Arachis hypogaea) allergen powder-dnfp] for treating peanut allergies.
FDA requests that all bacitracin for injection manufacturers voluntarily withdraw their product from the market because the benefits no longer outweig...