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Cook Group recommends improvements to an FDA draft guidance on the electronic submission eSTAR template.[ Price : $8.95]
FDA grants Blackrock Neurotech a breakthrough device designation for its MoveAgain Brain Computer Interface System that is intende...[ Price : $8.95]
CytoDyn begins resubmitting a rolling BLA for leronlimab, a CCR5 antagonist used in combination therapy with highly active antiret...[ Price : $8.95]
FDA says it is asking the Model-Informed Drug Development meeting requests and packages to include a credibility framework.[ Price : $8.95]
The journal Nature explores researchers questions about how FDA will act on two new amyloid-β therapies for Alzheimers diseas...[ Price : $8.95]
Researchers say FDA and NIH could do more to enforce ClinicalTrials.gov reporting requirements.[ Price : $8.95]
FDA authorizes the de novo marketing of AppliedVRs EaseVRx, a prescription-use immersive virtual reality system that uses cognitiv...[ Price : $8.95]
FDA grants Medtronic 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures.