Comment from Laboratory Corporation of America Holdings (Labcorp)
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Summary: Laboratory Corporation of America Holdings (Labcorp), a global life sciences company, submitted comments regarding the draft guidance on protocol deviations for clinical investigations. The company supports the guidance but requests further clarification on reporting requirements for "important" and "other" protocol deviations, specifically suggesting the use of international terminology and clearer definitions for administrative deviations.
Comments of Laboratory Corporation of America Holdings (Labcorp) to FDA Draft Guidance for Industry: Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices