21 CFR 314.200 - Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing

Cite as21 CFR 314.200
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31 practice notes
  • Food for human consumption: Food labeling— Dietary supplements; effect on structure or function of body; types of statements, definition,
    • United States
    • Federal Register January 06, 2000
    • January 6, 2000
    ...a decision making standard, and the development of an record for judicial review (see section 505(c)(1), (d), and (h) of the act and; 21 CFR 314.200.) Moreover, as far as FDA is aware, the constitutionality of the new drug approval process has never been challenged on First Amendment ground......
  • Bartlett v. Mutual Pharmaceutical Co., Inc., Civil No. 08-cv-358-JL.
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of New Hampshire
    • September 30, 2009
    ...on a proposal to withdraw approval of the application or the [ANDA] under [21 U.S.C. § 355(e)] and under the procedure set forth in [21 C.F.R. § 314.200], if the agency . . . (10) That the labeling for the drug product that is the subject of the [ANDA] is no longer consistent with that for ......
  • U.S. v. Undetermined Quantities of Art. of Drug, No. Civ. A. AW-00-1687.
    • United States
    • United States District Courts. 4th Circuit. United States District Court (Maryland)
    • June 12, 2001
    ...shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data and information." 21 C.F.R. § 314.200. "Substantial evidence does not consist of the expressed opinions of experts hired to testify on behalf of one party or the other. Instead, ......
  • Edison Pharmaceutical Co., Inc. v. Food and Drug Administration, Dept. of Health, Ed., and Welfare, No. 77-1636
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • March 21, 1979
    ...Pharmaceutical Co. v. FDA, 168 U.S.App.D.C. 273, 513 F.2d at 1067; 38 Fed.Reg. 17027 (1973). Edison then requested a hearing. 11 See 21 C.F.R. § 314.200(a)(2) (1978). The Commissioner concluded, Inter alia, that Edison had failed to set forth facts demonstrating the existence of a genuine a......
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9 cases
  • Bartlett v. Mutual Pharmaceutical Co., Inc., Civil No. 08-cv-358-JL.
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of New Hampshire
    • September 30, 2009
    ...on a proposal to withdraw approval of the application or the [ANDA] under [21 U.S.C. § 355(e)] and under the procedure set forth in [21 C.F.R. § 314.200], if the agency . . . (10) That the labeling for the drug product that is the subject of the [ANDA] is no longer consistent with that for ......
  • U.S. v. Undetermined Quantities of Art. of Drug, No. Civ. A. AW-00-1687.
    • United States
    • United States District Courts. 4th Circuit. United States District Court (Maryland)
    • June 12, 2001
    ...shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data and information." 21 C.F.R. § 314.200. "Substantial evidence does not consist of the expressed opinions of experts hired to testify on behalf of one party or the other. Instead, ......
  • Edison Pharmaceutical Co., Inc. v. Food and Drug Administration, Dept. of Health, Ed., and Welfare, No. 77-1636
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • March 21, 1979
    ...Pharmaceutical Co. v. FDA, 168 U.S.App.D.C. 273, 513 F.2d at 1067; 38 Fed.Reg. 17027 (1973). Edison then requested a hearing. 11 See 21 C.F.R. § 314.200(a)(2) (1978). The Commissioner concluded, Inter alia, that Edison had failed to set forth facts demonstrating the existence of a genuine a......
  • Breitmeyer v. Califano, Civ. A. No. 7-72854.
    • United States
    • United States District Courts. 6th Circuit. United States District Court (Western District Michigan)
    • September 28, 1978
    ...a more felicitous procedure for plaintiffs' purposes, in subpart C of part 314 of Title 21 of the Code of Federal Regulations. Under 21 CFR § 314.200(d) any interested person may request a hearing. The hearing, once granted, would extend to all issues relating to Essiac's status as a new dr......
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1 firm's commentaries
  • FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
    • United States
    • LexBlog United States
    • October 12, 2009
    ...a decision making standard, and the development of an record for judicial review (see section 505(c)(1), (d), and (h) of the act and; 21 CFR 314.200.) Moreover, as far as FDA is aware, the constitutionality of the new drug approval process has never been challenged on First Amendment ground......

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