Federal Register notice: FDA reopens until 5/5 the comment period for a 11/7/2019 notice on Best Practices in Drug and Biological Product Postmarket S...
FDA Review posts the Federal Register notices for the week ending 3/6/2020.
Federal Register notice: FDA makes available a draft guidance entitled Inclusion of Older Adults in Cancer Clinical Trials.
Federal Register notice: FDA makes available a final guidance entitled Policy for Diagnostics Testing in Laboratories Certified to Perform High Comple...
Federal Register notice: CDER announces its decision to continue Regulatory Project Management Site Tours and Regulatory Interaction Program.
FDA classifies as Class 1 a Becton Dickinson/CareFusion recall of 774,000 Alaris System infusion pumps and modules due to software and system errors.
The Justice Department files two False Claims Act lawsuits against SpineFrontier and related entities and executives, alleging that the company paid k...
FDA posts a draft guidance on Contact Dermatitis from Topical Drug Products for Cutaneous Application: Human Safety Assessment.