21 CFR 10.20 - Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure

Cite as21 CFR 10.20
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1717 practice notes
4 cases
  • Tummino v. Hamburg, No. 12–CV–763 (ERK)(VVP).
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • April 5, 2013
    ...their own consideration of materials that were not part of the Citizen Petition docket. The only regulation cited by the defendants is 21 C.F.R. § 10.20(c), which provides that “[i]nformation referred to or relied upon in a submission is to be included in full and may not be incorporated by......
  • Tummino v. Hamburg, No. 12-CV-763 (ERK)(VVP)
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • April 4, 2013
    ...their own consideration of materials that were not part of the Citizen Petition docket. The only regulation cited by the defendants is 21 C.F.R. § 10.20(c), which provides that "[i]nformation referred to or relied upon in a submission is to be included in full and may not be incorporated by......
  • Torpharm, Inc. v. Thompson, No. CIV.A. 03-0254(ESH).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • April 25, 2003
    ...how to establish that nebulous distinction. Nor do any of the regulations cited by the parties actually govern this issue. See, e.g., 21 C.F.R. § 10.20(e) (general rule for FDA docket submissions); 21 C.F.R. § 314.100(a) (timeframes for reviewing NDAs and ADAs); 314 C.F.R. § 314.101(a)(2) I......
  • Torpharm, Inc. v. Thompson, Civil Action No. 03-0254 (ESH) (D. D.C. 4/25/2003), Civil Action No. 03-0254 (ESH).
    • United States
    • U.S. District Court — District of Columbia
    • April 25, 2003
    ...how to establish that nebulous distinction. Nor do any of the regulations cited by the parties actually govern this issue. See, e.g., 21 C.F.R. § 10.20(e) (general rule for FDA docket submissions); 21 C.F.R. § 314.100(a) (timeframes for reviewing NDAs and ANDAs); 314 C.F.R. § 314.101(a)(2) ......
1713 provisions

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