FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the...
FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.
FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.
FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.
FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch uniformity and drug produ...
Federal Register notice: FDA makes available a final guidance entitled Advanced Manufacturing Technologies (AMT) Designation Program.
Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma.
Federal Register notice: FDA announces a 5/15 public meeting entitled Implementation of the Best Pharmaceuticals for Children Act and Pediatric Resear...
