21 CFR 10.115 - Good guidance practices

Cite as21 CFR 10.115
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2694 practice notes
22 cases
  • United States v. Franck's Lab, Inc., Case No. 5:10–cv–147–Oc–32TBS.
    • United States
    • U.S. District Court — Middle District of Florida
    • September 12, 2011
    ...policy changes to be “minor,” the agency did not publish a notice in the Federal Register or invite public comment prior to issuing it. 21 C.F.R. § 10.115 (setting forth “good guidance practices” for FDA to follow in developing, issuing and using guidance documents, which include notice-and......
  • United States v. Franck's Lab, Inc., Case No. 5:10-cv-147-Oc-32TBS
    • United States
    • United States District Courts. 11th Circuit. United States District Court of Middle District of Florida
    • September 12, 2011
    ...changes to be "minor," thePage 31agency did not publish a notice in the Federal Register or invite public comment prior to issuing it. 21 C.F.R. § 10.115 (setting forth "good guidance practices" for FDA to follow in developing, issuing and using guidance documents, which include notice-and-......
  • Hill Dermaceuticals, Inc. v. U.S. Food & Drug Admin., Civil Action No. 11-1950 (RCL)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • May 18, 2012
    ...Hill's citizen petition is "other guidance" contemplated by the regulation, that petition response is not a "guidance document" under 21 C.F.R. § 10.115(b)(3). Moreover, FDA did not give binding legal effect to any type of guidance document. Rather, FDA thoroughly examined the facts and pro......
  • In re Flonase Antitrust Litig..This Document Relates To: All Actionsroxane Laboratories Inc., Civil Action Nos. 08–3149
    • United States
    • United States District Courts. 3th Circuit. United States District Court (Eastern District of Pennsylvania)
    • June 2, 2011
    ...that manufacturers can use to develop their products. The FDA issues guidances in accordance with its “good guidance practices.” 21 C.F.R. § 10.115. According to those practices, the FDA must solicit public comments on a draft guidance by publishing a notice in the Federal Register. Id. Aft......
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15 firm's commentaries
  • A New Dawn For Challenges To FDA Actions? Kisor And The Tenuous Vitality Of Administrative Deference
    • United States
    • Mondaq United States
    • November 21, 2019
    ...139 S. Ct. at 2417 (quoting Exelon Generation Co. v. Local 15, Int'l Bhd. of Elec. Workers, 676 F.3d 566, 576-78 (7th Cir. 2012)). 36 21 C.F.R. § 10.115. 37 Kisor, 139 S. Ct. at 2426 (Gorsuch, J., concurring in the 38 Id. at 2424-26. 39 936 F.3d 628 (Aug. 10, 2019). 40 Id. at 648-59, 668. 4......
  • A New Dawn for Challenges to FDA Actions? Kisor and the Tenuous Vitality of Administrative Deference
    • United States
    • JD Supra United States
    • November 13, 2019
    ...139 S. Ct. at 2417 (quoting Exelon Generation Co. v. Local 15, Int’l Bhd. of Elec. Workers, 676 F.3d 566, 576-78 (7th Cir. 2012)). 21 C.F.R. § 10.115. Kisor, 139 S. Ct. at 2426 (Gorsuch, J., concurring in the Id. at 2424-26. 936 F.3d 628 (Aug. 10, 2019). Id. at 648-59, 668. Id. at 675 (quot......
  • HHS ends FDA Unapproved Drugs Initiative, seeks to limit which drugs require FDA approval
    • United States
    • JD Supra United States
    • December 2, 2020
    ...change of this magnitude must be published first as a draft guidance for public comment before the policy shift can be finalized. See 21 CFR 10.115(g). Although these FDA regulations do not specifically apply to HHS, the Secretary of HHS is responsible for executing the Federal Food, Drug, ......
  • Guidance for Dietary Supplement Industry from the FDA
    • United States
    • LexBlog United States
    • October 12, 2009
    ...supplements. This is a Level 2 guidance document published for immediate implementation in accordance with FDA’s good guidance practices (21 CFR 10.115). The regulations are binding and have the force and effect of law. However, this guidance document represents the agency’s current thinkin......
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2 books & journal articles
  • White House Orders, Bulletins, and Memoranda on Regulation
    • United States
    • Federal Administrative Procedure Sourcebook, Fifth Edition 2016
    • January 1, 2016
    ...57 See FDA, “Administrative Practices and Procedures; Good Guidance Practices,” 65 FR 7321, 7322-23 (proposed Feb. 14, 2000). 58 21 C.F.R. § 10.115; 65 FR 56,468 (Sept. 19, 59 Pub. L. No. 106-554, § 515(a) (2000). The Information Quality Act was developed as a supplement to the Paperwork Re......
  • Naked Price and Pharmaceutical Trade Secret Overreach.
    • United States
    • Yale Journal of Law & Technology Vol. 22 Nbr. 1, January 2020
    • January 1, 2020
    ...("Guidance documents describe FDA's interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated (41) See Robin Feld......

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