21 C.F.R. 1.1 - General
| Cite as | 21 C.F.R. 1.1 |
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10 practice notes
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Securing Updated and Necessary Statutory Evaluations Timely
...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......
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Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
...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......
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Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety
...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......
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Com. v. Haseotes
...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......
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3 cases
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Com. v. Haseotes
...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......
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Holk v. Snapple Beverage Corp., Civil Action No. 07-3018 (MLC).
...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......
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Veal v. Citrus World, Inc., CASE NO. 2:12-CV-801-IPJ
...("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
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Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety
...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......
6 provisions
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Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
...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......
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Securing Updated and Necessary Statutory Evaluations Timely
...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......
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Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
...Requirements. 1100.3 Definitions. 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 Sec. 1100.1 Scope. Option 1 In addition to FDA's authority over cigarettes, cigarette tobacco, roll-your-own tobacco, ......
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Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs
...that reference to the definitions in section 201 of the FD&C Act was intentionally omitted (71 FR 51276 at 51285). Consistent with 21 CFR 1.1(b), this final rule clarifies that the definitions in section 201 of the FD&C Act apply to the terms used in part Establishment. We proposed ......
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