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FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under...[ Price : $8.95]
FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Under...[ Price : $8.95]
FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.[ Price : $8.95]
FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.[ Price : $8.95]
FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch unifo...[ Price : $8.95]
Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diff...[ Price : $8.95]
FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.[ Price : $8.95]
FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.