21 CFR 10.115 - Good guidance practices
| Cite as | 21 CFR 10.115 |
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2694 practice notes
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Sanitary Transportation of Human and Animal Food
...take to comply with this rule. We would not include requirements in any guidance because under our good guidance practices regulation (21 CFR 10.115), guidance documents do not establish legally enforceable rights or (Comment 25) A comment addressing the transportation of RACs by farms agre......
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Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
...food safety regulatory requirements under FDA's jurisdiction. We issue guidances, in accordance with our regulations in Sec. 10.115 (21 CFR 10.115) for ``good guidance practices,'' to describe our interpretation of or policy on a regulatory issue. Guidances do not establish legally enforcea......
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Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
...safety regulatory requirements under FDA's jurisdiction. The Agency issues guidances, in accordance with its regulations in Sec. 10.115 (21 CFR 10.115) for ``good guidance practices,'' to describe its interpretation of or policy on a regulatory issue. Guidances do not establish legally enfo......
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Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
...IV.C.2 of this document). We will provide advance notice, in accordance with FDA's good guidance practice regulations under Sec. 10.115 (21 CFR 10.115), so that affected parties will have adequate time to convert to any new format or software. In addition, we expect that such format or soft......
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22 cases
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United States v. Franck's Lab, Inc., Case No. 5:10–cv–147–Oc–32TBS.
...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......
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United States v. Franck's Lab, Inc., Case No. 5:10-cv-147-Oc-32TBS
...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-......
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Hill Dermaceuticals, Inc. v. U.S. Food & Drug Admin., Civil Action No. 11-1950 (RCL)
...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......
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In re Flonase Antitrust Litig..This Document Relates To: All Actionsroxane Laboratories Inc., Civil Action Nos. 08–3149
...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
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A New Dawn For Challenges To FDA Actions? Kisor And The Tenuous Vitality Of Administrative Deference
...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......
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A New Dawn for Challenges to FDA Actions? Kisor and the Tenuous Vitality of Administrative Deference
...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......
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HHS ends FDA Unapproved Drugs Initiative, seeks to limit which drugs require FDA approval
...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, ......
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Guidance for Dietary Supplement Industry from the FDA
...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
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White House Orders, Bulletins, and Memoranda on Regulation
...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......
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Naked Price and Pharmaceutical Trade Secret Overreach.
...("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......