AdvaMed cautions FDA not to incorporate an International Medical Device Regulators Forum document on software as a medical device directly into an age...
FDA Review posts the latest Federal Register notices for the week ending 9/1/2017.
Federal Register notice: FDA determines that Janssen Research & Development Nizoral (ketoconazole) tablets, 200 milligrams (mg), were not withdrawn fr...
FDA approves Pfizers once-withdrawn Mylotarg (gemtuzumab ozogamicin) for treating adults with newly diagnosed acute myeloid leukemia whose tumors expr...
Federal Register notice: FDA announces the availability of a guidance entitled Procedures for Meetings of the Medical Devices Advisory Committee.
FDA releases a draft guidance on electronic submission of Risk Evaluation and Mitigation Strategies.
FDA warns medical professionals to not use alcohol pads or benzalkonium chloride antiseptic towelettes made by China-based Foshan Flying Medical Produ...
FDA, National Cancer Institute and the Society of Urologic Oncology announce an 11/28 public workshop to improve the conduct of adjuvant clinical tria...