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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.[ Price : $8.95]
FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.[ Price : $8.95]
FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for...[ Price : $8.95]
FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...[ Price : $8.95]
FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Tuesday, January 2, 2024.[ Price : $8.95]
FDA approves a Merck NDA for Welireg (belzutifan) for treating patients with advanced kidney cancer following a programmed death r...[ Price : $8.95]
FDA approves a Glaukos Corp. NDA for iDOSE TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for reduc...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of the indications for mantle cell lymphoma and marginal zone lymphoma for Pharmac...