Federal Register notice: FDA announces the availability of a draft guidance on Identifying Trading Partners Under the Drug Supply Chain Security Act....
CDER and ORA announce a concept of operations agreement to integrate facility evaluations and inspections for human drugs.
FDA grants Syros Pharmaceuticals an orphan drug designation for SY-1425 for treating acute myeloid leukemia.
President Trump signs the FDA Reauthorization Act of 2017 that renews the agencys user fee programs for another five years.
FDA says it is carefully evaluating prescription opioid medications approved to treat cough in children, and it has planned a 9/11 Pediatric Advisory ...
Federal Register notice: FDA determines the patent restoration purposes the regulatory review period for Acrux DDS Pty. Ltd.s Recuvyra (fentanyl) for ...
A July inspection at outsourcing drug manufacturer Leesar, Inc. (Fort Myers, FL) finds that the firms aseptic processing areas were deficient regardin...
Federal Register notice: CDER has announced its support for the 3.1 version of Clinical Data Interchange Standards Consortium Standard for Exchange of...