21 C.F.R. §3.2 - Definitions

Cite as21 C.F.R. §3.2
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2 books & journal articles
  • Regulatory and Enforcement Framework
    • United States
    • ABA Antitrust Library Pharmaceutical Industry Antitrust Handbook. Second Edition
    • December 8, 2018
    ...394 U.S. 784, 798 (1969); see also Brown & Williamson , 529 U.S. at 165 (quoting Bacto-Unidisk ). 7. 21 U.S.C. § 353(g)(1). 8. 21 C.F.R. §§ 3.2(e)(1) & 4.3 (stating that each constituent part is regulated as its constituent part); Miller v. Mylan Inc. (In re Estate of Kelly), 741 F.3d 674 (......
  • Human-nonhuman chimeras in embryonic stem cell research.
    • United States
    • Harvard Journal of Law & Technology Vol. 21 No. 1, September 2007
    • September 22, 2007
    ...device, or cosmetic that is adulterated or misbranded"); see also id. § 321(h) (defining "device"). (148.) Id. § 353(g) (2000). (149.) 21 C.F.R. § 3.2(e) (2006) (defining "combination products" as including such combinations as drug/device, drug/biologic, and (150.) Public Health Service Ac......

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