FDA posts three Form FDA-483s issued to Indias Biocon Biologics following three on-site August inspections at the companys seven manufacturing sites i...
CDER Office of Generic Drugs director Sally Choe decides to leave FDA effective 10/8 to pursue opportunities outside the agency.
Former New York cannabis programs director Norman Birenbaum joins CDERs Office of the Center Director as a senior public health advisor on cannabis is...
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FDA posts a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children.
