Federal Register notice: FDA makes available a final guidance entitled Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Secu...
Federal Register FDA determines for patent extension purposes the regulatory review period for Biohaven Pharmaceuticals migraine drug Nurtec ODT (rime...
Federal Register notice: FDA seeks comments on a new information collection involving a pediatric device survey.
Former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger says FDA is likely to expand its use of new FDA Medic...
FDA posts a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children.
FDA grants QT Imaging a 510(k) clearance for its QTscan to calculate the fibroglandular volume of the breast and the ratio of that to total breast vol...
Philips Respironics recalls (Class 1) certain BiPAP (bi-level positive airway pressure) ventilators that may contain a plastic contaminated with a non...
FDA releases an immediately-in-effect guidance entitled Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA...
