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human data studies

Defined in 1 place of the United States Code.

The term "human data studies" means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies.

Source

  • 2020–present21 U.S.C. § 355hFood and Drugs · Regulation of certain nonprescription drugs that are marketed without an approved drug application · in this section