21 C.F.R. §312.23 - IND content and format
| Cite as | 21 C.F.R. §312.23 |
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24 cases
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Advanced Integrative Med. Sci. Inst., PLLC v. Garland, 21-70544
...Sponsors must provide specified information and comply with a long list of requirements to obtain approval of an IND application. See 21 C.F.R. § 312.23. If the application is approved, then the sponsor must embark on three phases of clinical trials. An individual may be able to access an i......
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Abigail Alliance for Better Access v. Von Eschenbach, 04-5350.
...355(i)(1); see also 21 C.F.R. pt. 312, 495 F.3d 698 containing detailed information establishing that human testing is appropriate, see 21 C.F.R. § 312.23. Once the application for human testing has been approved, see id. § 312.20, several phases of clinical testing begin. The Alliance's am......
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Abigail Alliance v. Von Eschenbach, 04-5350.
...see id. § 355(i)(1); see also 21 C.F.R. pt. 312, containing detailed information establishing that human testing is appropriate, see 21 C.F.R. § 312.23. Testing a new drug for safety and effectiveness in treating humans generally requires three or sometimes four phases. See id. § 312.21. Ph......
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Mohr v. TARGETED GENETICS, INC., 09-3170.
...applicant must have subjected biologically active agents of the proposed drug to comprehensive animal and human tissue testing. See 21 C.F.R. § 312.23(a). The applicant may commence human clinical trials if the FDA does not request more information or seek modifications to the testing proto......
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2 firm's commentaries
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FDA Collection And Labeling Protocols For Use Of Convalescent Plasma As A Treatment For COVID-19
...COVID-19 convalescent plasma INDs must meet FDA's IND regulations relating to chemistry, manufacturing, and control information (see 21 CFR 312.23(a)(7) and 21 CFR 312.305(b)(2)(vi)). To meet these requirements, FDA recommends that IND applications include information that the COVID-19 plas......
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Recognizing the Vital Contributions of Animals to Biomedical Research
...on any risks anticipated based on the results of pharmacologic and toxicological data collected during studies of the drug in animals (21 CFR 312.23(a)(8)). These basic safety tests are most often performed in rats and dogs. The studies are designed to permit the selection of a safe startin......
4 books & journal articles
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Regulatory and Enforcement Framework
...thousands of people are included), vary in design, and the drug is often given for a longer duration. Phase III trials 18. See 21 C.F.R. § 312.23 (IND content and format). require gathering additional data and evaluating the risk versus benefit, dosing, and other information. This is the po......
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Regulating Clinical Research: Informed Consent, Privacy, and Irbs
...the jurisdiction of the Food and Drug Administration, including any food, drug, and device intended for human or animal use....) [38] 21 C.F.R. § 312.23(a) (2002). Medical research for drugs is conducted in three or four phases of clinical trials. See generally § 312.23. In Phase I, the new......
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The Drug Approval Process. An Overview
...to four years. Karki, supra note 4. 8. Karki, supra note 4. 9. See 21 U.S.C. § 355(i). 10. Hathaway et al., supra note 5, at 676; see 21 C.F.R. § 312.23. 11. Hathaway et al., supra note 5, at 676; see 21 C.F.R. § 312.23. 12. The IND will go into effect 30 days after the FDA’s receipt, unles......
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Germline Editing Using CRISPR: Why a Moratorium Is Not the Solution (From the 2020 Schwab Family Law Essay Contest)
...information-about-self-administration-gene-therapy. 41. See 21 C.F.R. §§ 312.20, 312.23; Investigational New Drug Applications (INDs) for CBER-Regulated Products , U.S. FooD & Drug aDmin., https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/investigational-new-dru......