Studies a U.S. FDA-regulated Drug Product

(39) Studies a U.S. FDA-regulated Drug Product means a clinical trial studies a drug product (including a biological product) subject to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262).

Source

42 CFR § 11.10

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Scoping language

The following definitions apply to terms used in this part:

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