21 CFR 600.3 - Definitions

Cite as21 CFR 600.3
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40 practice notes
  • Human drugs and biological products: Prescription drug products; labeling requirements,
    • United States
    • Federal Register January 24, 2006
    • December 7, 2005
    ...prescribed in regulations (section 351(d) of the PHS Act). The ``potency'' of a biological product includes its effectiveness (21 CFR 600.3(s)). Section 351(b) of the PHS Act prohibits false labeling of a biological product. FDA's regulations in part 201 apply to all prescription drug produ......
  • Teva Pharmaceuticals USA, Inc. v. United States Food and Drug Administration, 123120 DCDC, C. A. 20-808 (BAH)
    • United States
    • Federal Cases United States District Courts District of Columbia
    • December 31, 2020
    ...sections of the Code of Federal Regulations. See Id. at 807 (proposing to codify FDA's definition of “protein” at 21 C.F.R. § 600.3(h)(6) and FDA's definition of “chemically synthesized polypeptide” at 21 C.F.R. § 600.3(h)(7)). Further, though the structure of secti......
  • Commercializing Stem Cell-Based Therapies: Meeting NIH and FDA Requirements by Kalah Auchincloss
    • United States
    • JD Supra United States
    • September 9, 2009
    ...23 ISSCR Guidelines at Recommendation 4; see 21 C.F.R. § 1271.85. 24 42 U.S.C. § 262 et seq. (2009); 21 C.F.R. §§ 610.10, 610.11, 610.13, 600.3 (2009). 25 21 C.F.R. Part 312 (2009). Among other things, the IND application must include a commitment from the sponsor: (1) not to begin clinical......
  • 484 F.Supp.2d 289 (E.D.Pa. 2007), Civ. A. 06-1111, Sykes v. Glaxo-SmithKline
    • United States
    • Federal Cases United States District Courts 3th Circuit Eastern District of Pennsylvania
    • March 28, 2007
    ...vaccines and Bayer's immune globulin are "biological products," Page 293 as that term is defined in FDA regulations. See 21 C.F.R. § 600.3(h). For all biological products containing a preservative, the FDA must be satisfied that the preservative is safe before the product can be A......
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10 cases
  • Teva Pharmaceuticals USA, Inc. v. United States Food and Drug Administration, 123120 DCDC, C. A. 20-808 (BAH)
    • United States
    • Federal Cases United States District Courts District of Columbia
    • December 31, 2020
    ...sections of the Code of Federal Regulations. See Id. at 807 (proposing to codify FDA's definition of “protein” at 21 C.F.R. § 600.3(h)(6) and FDA's definition of “chemically synthesized polypeptide” at 21 C.F.R. § 600.3(h)(7)). Further, though the structure of secti......
  • 484 F.Supp.2d 289 (E.D.Pa. 2007), Civ. A. 06-1111, Sykes v. Glaxo-SmithKline
    • United States
    • Federal Cases United States District Courts 3th Circuit Eastern District of Pennsylvania
    • March 28, 2007
    ...vaccines and Bayer's immune globulin are "biological products," Page 293 as that term is defined in FDA regulations. See 21 C.F.R. § 600.3(h). For all biological products containing a preservative, the FDA must be satisfied that the preservative is safe before the product can be A......
  • 459 F.Supp.2d 1255 (S.D.Fla. 2005), 05-60021, United States v. Livdahl
    • United States
    • Federal Cases United States District Courts 11th Circuit Southern District of Florida
    • October 17, 2005
    ...the prevention, treatment or cure of diseases or injuries of man," and omit the statutory reference to "condition." 21 C.F.R. Part 600.3(h). Since facial wrinkles are not a disease or injury, at least according to Black's Law Dictionary's definition of these terms, the defend......
  • 662 F.2d 1268 (8th Cir. 1981), 80-1886, Loge v. United States
    • United States
    • Federal Cases United States Courts of Appeals Court of Appeals for the Eighth Circuit
    • November 6, 1981
    ...in 21 C.F.R. § 601.25; (7) failing to enact regulations which would assure the safety of trivalent oral polio vaccine as defined in 21 C.F.R. § 600.3(p); (8) subjecting Mrs. Loge to shed virus inoculation without her knowledge or (9) failing to approve a stronger package insert warning abou......
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4 firm's commentaries
26 provisions
  • Human drugs and biological products: Prescription drug products; labeling requirements,
    • United States
    • Federal Register January 24, 2006
    • December 7, 2005
    ...prescribed in regulations (section 351(d) of the PHS Act). The ``potency'' of a biological product includes its effectiveness (21 CFR 600.3(s)). Section 351(b) of the PHS Act prohibits false labeling of a biological product. FDA's regulations in part 201 apply to all prescription drug produ......
  • Human drugs and biological products: Human gene therapy or xenotransplantation; data and information disclosure,
    • United States
    • Federal Register January 18, 2001
    • December 20, 2000
    ...these definitions to the section of the regulations which currently includes definitions of other terms applicable to biological products (21 CFR 600.3). b. Scope. Proposed Sec. 601.52(b) would describe the scope of the proposed regulation. Consistent with the use of the terms ``human gene ......
  • Definition of the Term “Biological Product”
    • United States
    • Federal Register December 12, 2018
    • December 12, 2018
    ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 600 Docket No. RIN 0910-AH57 Definition of the Term ``Biological Product'' AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. ---------------------------------------------------------------------......
  • Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling
    • United States
    • Federal Register December 04, 2014
    • December 4, 2014
    ...prescribed in regulations (section 351(d) of the PHS Act). The ``potency'' of a biological product includes its effectiveness (21 CFR 600.3(s)). Section 351(b) of the PHS Act prohibits false labeling of a biological product. FDA's regulations in part 201 apply to all prescription drug produ......
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