Adequate and well-controlled studies

CurrencyCurrent through May 31, 2023
Citation 21 C.F.R. §314.126
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1 cases
  • United States v. Hakim
    • United States
    • U.S. District Court — Southern District of New York
    • May 26, 2020
    ...v. United States , 629 F.2d 795, 802 (2d Cir. 1980). The FDA has issued regulations defining "adequate and well-controlled studies," 21 C.F.R. § 314.126, which "elaborates" on the substantial evidence test. Weinberger , 412 U.S. at 649, 93 S.Ct. 2469. The Second Circuit Court of Appeals has......

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