The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
Immuron Limited announced the submission of the Clinical Study Report for its Phase 2 clinical trial of Travelan® (IMM-124E) to the FDA, which demonstrated statistically significant immunological and ...
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
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