FDA Proposes Expansion of Clinical Investigator Disqualification in New Rule

On April 13, 2011, the Food and Drug Administration (FDA) proposed a rule that, if finalized, will expand the scope and consequences of clinical investigator disqualifications. Under the proposed rule, a clinical investigator, including a sponsor-investigator, disqualified pursuant to FDA regulations (21 C.F.R. Parts 312, 511, or 812) will be ineligible to receive specified test articles. Thus, under the proposed rule, a disqualified investigator would not be allowed to conduct or participate in clinical investigation or obtain a marketing permit for any FDA-regulated products, rather than just the specific kind of test article that was the subject of the disqualification. This increases the importance of a disqualification because a disqualified investigator would no longer be allowed to participate in research supporting marketing applications for any drugs, biologics, devices, new animal drugs, foods, including dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products. The FDA is accepting comments on the proposed rule through July 12, 2011.

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