As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
Napo Obtains IRB Approval For Phase 3 Clinical Trial Protocol For Crofelemer In HIV/AIDS Diarrhea Assessment Napo Pharmaceuticals, Inc. announces today that it has received approval from the principal ...
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