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FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical devic...[ Price : $8.95]
FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.[ Price : $8.95]
FDA requires safety labeling changes about Guillain-Barr syndrome risks for Pfizers Abrysvo (respiratory syncytial virus vaccine) ...[ Price : $8.95]
FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.[ Price : $8.95]
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FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Under...[ Price : $8.95]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 approves Galdermas Nemluvio to treat some dermatitis patients aged 12 and older.