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FDA warns Chinas Huangshi Hygienec Material Medicine Co. about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
Vigil Neuroscience ends its Phase 2 long-term extension study of investigational therapy iluzanebart based on disappointing study ...[ Price : $8.95]
FDA posts a draft guidance entitled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001...[ Price : $8.95]
FDA warns Medley, FL-based Evi Labs about CGMP violations in its work as a contract drug manufacturer.[ Price : $8.95]
FDA publishes a draft guidance entitled Transfer of a Premarket Notification (510(k)) Clearance Questions and Answers.[ Price : $8.95]
The Government Accountability Office says there are things HHS, FDA, and other units should do to help create a coordinated nation...[ Price : $8.95]
Two former FDA officials add their names to a class-action wrongful termination lawsuit alleging the federal government knowingly ...[ Price : $8.95]
Anonymous and named sources raise questions for NBC News about FDAs use of internal AI tools in product reviews and approvals.