FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mut...
Three Hyman, Phelps attorneys say an HHS announcement withdrawing a Trump administration policy on FDA review of laboratory-developed tests leaves man...
FDA sends Fennec Pharmaceuticals a second complete response letter on its NDA for Pedmark (sodium thiosulfate, intravenous) for preventing ototoxicity...
Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Technical Electronic Product Radiation Safety Standards Committ...
Federal Register notice: FDA makes available a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug ...
Drug companies and other stakeholders respond to an FDA draft guidance on using electronic health records and claims data in real-world data studies.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pharma Mars Zepzelca (lurbinectedin).
Federal Register notice: FDA seeks comments on an information collection revision entitled Prescription Drug User Fee Program.