21 C.F.R. 1.1 - General

Cite as21 C.F.R. 1.1
    • This document is available in original version only for vLex customers

      View this document and try vLex for 7 days
    • TRY VLEX
10 practice notes
  • Securing Updated and Necessary Statutory Evaluations Timely
    • United States
    • Centers For Medicare And Medicaid Services,Public Health Service,The Inspector General Office
    • Invalid date
    ...over) when promulgating future regulations. --------------------------------------------------------------------------- \106\ See, e.g., 21 CFR 1.1(b) (``the definitions and interpretations of terms contained in sections 201 and 900 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321......
  • Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
    • United States
    • Federal Register January 09, 2017
    • January 9, 2017
    ...1100 is revised to read as follows: Authority: 21 U.S.C. 387a(b), 387f(d); Secs. 901(b) and 906(d), Pub. L. 111-31; 21 CFR 16.1 and 1107.1; 21 CFR 1.1, 1.20, 14.55, 17.1, and 17.2. Section 1100.5 is issued under 21 U.S.C. 321, 353(g), and 371(a); 21 CFR Part 1100 is amended by adding Sec. 1......
  • Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety
    • United States
    • Iowa Law Review Nbr. 99-1, November 2013
    • November 1, 2013
    ...warnings in labeling, even in black box form. See id. 287 . For an overview of general FDA administrative proceedings, see 21 C.F.R. § 1.1 (2013). 288 . For an overview of general administrative procedures for a citizen petition, see id. § 10.30. 289 . Id. § 10.30(h). 290. See id. § 13.1. 2......
  • Com. v. Haseotes
    • United States
    • United States State Supreme Judicial Court of Massachusetts
    • June 23, 1969
    ...See 9 C.F.R. § 317.8 (1968) regulating the contents of prepackaged meat; 21 U.S.C. § 453(h)(5) (poultry); 21 U.S.C. § 372a (1964), and 21 C.F.R. §§ 1.1, 1.8, 5.7, 36.3--36.31, 37.1--37.3 (1969). But §§ 56B imposes no standard. We think it fanciful to suggest that the opportunity for some ve......
  • Request a trial to view additional results
3 cases
  • Com. v. Haseotes
    • United States
    • United States State Supreme Judicial Court of Massachusetts
    • June 23, 1969
    ...See 9 C.F.R. § 317.8 (1968) regulating the contents of prepackaged meat; 21 U.S.C. § 453(h)(5) (poultry); 21 U.S.C. § 372a (1964), and 21 C.F.R. §§ 1.1, 1.8, 5.7, 36.3--36.31, 37.1--37.3 (1969). But §§ 56B imposes no standard. We think it fanciful to suggest that the opportunity for some ve......
  • Holk v. Snapple Beverage Corp., Civil Action No. 07-3018 (MLC).
    • United States
    • U.S. District Court — District of New Jersey
    • June 13, 2008
    ...See 21 U.S.C. § 332; 21 C.F.R. § 7.40. The FDA has promulgated comprehensive regulations pursuant to its authority under the FFDCA. 21 C.F.R. § 1.1 et seq.; see 21 U.S.C. § 341 ("Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest......
  • Veal v. Citrus World, Inc., CASE NO. 2:12-CV-801-IPJ
    • United States
    • United States District Courts. 11th Circuit. United States District Court of Northern District of Alabama
    • January 8, 2013
    ...("FDCA"), 21 U.S.C. §§ 301 et seq., and the implementing regulations of the Food and Drug Administration ("FDA"), 21 C.F.R. §§ 1.1 et seq., govern food and beverage labeling. The Federal Food, Drug, and Cosmetic Act (FDCA) empowers the Food and Drug Administration (FDA) ......
1 books & journal articles
6 provisions

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT