FDA Expands Scope of Clinical Investigator Disqualification

FDA recently published a final rule amending 21 CFR 16, 312, 511 and 812.

Under the new rule, which will become effective on May 30, 2012, a determination that a clinical investigator is ineligible to receive one kind of test article will automatically disqualify that individual from receiving other types of test articles, and from conducting clinical investigations in support of any research or marketing application, involving any type of FDA-regulated product (a fairly lengthy list that includes drugs, biologics, devices, new animal drugs, foods, dietary supplements that fall under FDA regulation, infant formulas, food and color additives and tobacco products).

The new rule is intended to enhance human research protections and to ensure FDA regulatory decisions are made on the basis of reliable, scientifically sound data.

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