VRBPAC January 26, 2023 Meeting Announcement
On This Page Date: January 26, 2023 Time: 8:30 a.m. – 5:30 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on...Information for Institutional Review Boards (IRBs)
On this page, you will find information about:What is expanded access?Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational...Submission Data
CDER, CBER and CDRH Expanded Access INDs and Protocols (2019-2023)On this page you will find:The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) expanded access submission receipt reports for INDs and...FDA approves belantamab mafodotin-blmf for relapsed or refractory mult
On October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or...SPARTAN may be harmful due to hidden drug ingredient
[10-23-2025] The Food and Drug Administration is advising consumers not to purchase or use SPARTAN, a product promoted and sold for male sexual enhancement on various websites, including www.vroxusa.com, and possibly in some retail stores.FDA laboratory analysis...FDA Publishes Filing Checklists to Prevent Submission Delays
For Immediate Release: October 23, 2025 The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable. By...Information for Consumers, Health Care Professionals and Industry
FDA’s role in drug recallsA recall may be recommended or requested by FDA or initiated voluntarily at any time by a company. FDA’s role in a recall is to oversee a company’s recall strategy and ensure adequate steps were taken to implement the recall.FDA evaluates the...2024 First Generic Drug Approvals
76218492Prucalopride TabletsNovitium Pharma LLCMotegrity Tablets12/26/2024For the treatment of chronic idiopathic constipation in adults75215971Deutetrabenazine TabletsAurobindo Pharma LimitedAustedo Tablets12/26/2024For the treatment in adults of Chorea associated...Click To Verify Security & Validation
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