21 CFR 312.21 - Phases of an investigation
| Cite as | 21 CFR 312.21 |
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84 practice notes
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Clinical Trials Registration and Results Submission
...where ``clinical investigation'' has the meaning given in 21 CFR 312.3 or any successor regulation and phase I has the meaning given in 21 CFR 312.21 or any successor This proposed rule, in Sec. 11.10, adopts the statutory definitions of all three of these terms, replacing the phrase ``phas......
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Abigail Alliance v. Von Eschenbach, No. 04-5350.
...subjects to determine "the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness." 21 C.F.R. § 312.21(a). It takes approximately one year to conduct Phase I testing.1 FDA counsel acknowledged at oral argument that drugs that survive this ph......
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Mohr v. TARGETED GENETICS, INC., No. 09-3170.
...may commence human clinical trials if the FDA does not request more information or seek modifications to the testing protocols. See 21 C.F.R. §§ 312.21-23, Abbott further states that, during the next stage of the approval process, there are three phases of clinical trials. See 21 C.F.R. § 3......
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Miller v. Pfizer Inc. (Roerig Division), Civil Action No. 99-2326-KHV.
...of a practitioner licensed by law to administer such drugs." 21 U.S.C. § 353(b). 15. See 21 C.F.R. § 312.2. 16. See 21 C.F.R. §§ 312.20, 312.21. 17. See 21 C.F.R. § 18. See 21 C.F.R. § 312.20. 19. See 21 C.F.R. § 314. 20. See 21 C.F.R. § 314.50. 21. 21 U.S.C. § 355(d). 22. 21 U.S.C. § 355(d......
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64 cases
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Abigail Alliance v. Von Eschenbach, No. 04-5350.
...subjects to determine "the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness." 21 C.F.R. § 312.21(a). It takes approximately one year to conduct Phase I testing.1 FDA counsel acknowledged at oral argument that drugs that survive this ph......
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Mohr v. TARGETED GENETICS, INC., No. 09-3170.
...may commence human clinical trials if the FDA does not request more information or seek modifications to the testing protocols. See 21 C.F.R. §§ 312.21-23, Abbott further states that, during the next stage of the approval process, there are three phases of clinical trials. See 21 C.F.R. § 3......
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Miller v. Pfizer Inc. (Roerig Division), Civil Action No. 99-2326-KHV.
...of a practitioner licensed by law to administer such drugs." 21 U.S.C. § 353(b). 15. See 21 C.F.R. § 312.2. 16. See 21 C.F.R. §§ 312.20, 312.21. 17. See 21 C.F.R. § 18. See 21 C.F.R. § 312.20. 19. See 21 C.F.R. § 314. 20. See 21 C.F.R. § 314.50. 21. 21 U.S.C. § 355(d). 22. 21 U.S.C. § 355(d......
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Wyeth, Inc. v. Weeks, 1101397.
...FDA, which includes information about the chemistry, manufacturing, pharmacology, and toxicology of the drug. See 21 U.S.C. § 355(b) ; 21 C.F.R. § 312.21. The IND also includes pre-clinical data (animal pharmacology and toxicology), and protocols for human testing must be detailed.4 After c......
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6 firm's commentaries
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Pro Te Solutio - Vol. 5 No. 2, March 2012
...INDA to the FDA if it wishes to conduct a clinical investigation of a new drug and cannot begin such a trial until it has done so. Under 21 CFR § 312.21, an INDA may be submitted for one of more phases of an investigation. The FDA has to review the application to assure the safety of all th......
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Annual Review of Federal Securities Regulation - The Business Lawyer, Vol. 70, Iss. 3
...regulations require three phases of clinical trials—which may overlap— to assess the efficacy and safety of potential new treatments. 21 C.F.R. § 312.21. Phase [I] tests drug’s efficacy and safety on a small number of patients. Phase [II] is a controlled clinical study in which various dose......
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Federal Right To Try Legislation Is It Any Better?
...and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. 21 C.F.R. §312.21(a). Phase 1 studies are small, with between "20 to 80" study participants. Getting down to litigation-related brass tacks, S.4789 contains a subse......
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Federal Right To Try Legislation – Is It Any Better?
...and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. 21 C.F.R. §312.21(a). Phase 1 studies are small, with between “20 to 80” study participants. Id. Getting down to litigation-related brass tacks, S.4789 contains a s......
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3 books & journal articles
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Regulating Clinical Research: Informed Consent, Privacy, and Irbs
...and the Tribunal for the Former Yugoslavia, 30 VAL. L. REV. 895, 896 (1996). [18] Vanderpool, supra note 2, at 8. [19] Id. [20] See 21 C.F.R. § 312.21(a) (2002). Human research studies are often called "clinical trials." Id. [21] HORNBLUM, supra note 15, at 43. [22] HORNBLUM, supra note 15,......
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The Drug Approval Process. An Overview
...Act: Is a Faster Food and Drug Administration Always a Better Food and Drug Administration?, 60 FOOD & DRUG L.J. 261, 267 (2005); see 21 C.F.R. § 312.21. 14. See James M. Wood & Roxanne M. Gariby, Hoarding Away Science: Towards a More Transparent View of Health and Online Registries for Ind......
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Regulating the research enterprise: international norms and the right to bodily integrity in human experiment litigation.
...INT'L L. 401,407 108 (1997). (39) A slogan of ACT-UP (AIDS Coalition to Unleash Power), quoted in Annas. supra note 38, at 312. (40) 21 C.F.R. Sec. 312.21, Phases of an investigation. Compare the following description found on a National Institutes of Health website that provides informatio......