Four stakeholders submit specific technical concerns about an FDA draft guidance on topical ophthalmic drug quality considerations.
FDA approves a U.S. WorldMeds NDA for eflornithine for reducing the risk of relapse in certain adult and pediatric patients with high-risk neuroblasto...
Sens. Durbin and Blumenthal ask the Government Accountability Office to update its 2011 report on FDA oversight of medical device recalls, given a sex...
FDA warns Northridge, CA-based Novid Group that it is illegally distributing an unapproved and misbranded over-the-counter antihistamine/nasal deconge...
Vertex Pharmaceuticals says it will advance selective NaV1.8 inhibitor VX-548 into pivotal Phase 3 studies based on positive results from its Phase 2 ...
Federal Register notice: FDA makes available a draft guidance entitled Advanced Manufacturing Technologies Designation Program.
Federal Register notice: FDA creates the Genetic Metabolic Diseases Advisory Committee to review and make recommendations on investigational or market...
FDA says HHS has started reviewing the agencys proposed reorganization for a unified Human Foods Program and a revised Office of Regulatory Affairs.
