21 CFR 312.21 - Phases of an investigation

Cite as21 CFR 312.21
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84 practice notes
  • Clinical Trials Registration and Results Submission
    • United States
    • Federal Register November 21, 2014
    • November 21, 2014
    ...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......
  • Abigail Alliance v. Von Eschenbach, No. 04-5350.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • May 2, 2006
    ...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......
  • Mohr v. TARGETED GENETICS, INC., No. 09-3170.
    • United States
    • United States District Courts. 7th Circuit. United States District Courts. 7th Circuit. Central District of Illinois
    • March 3, 2010
    ...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......
  • Miller v. Pfizer Inc. (Roerig Division), Civil Action No. 99-2326-KHV.
    • United States
    • United States District Courts. 10th Circuit. United States District Courts. 10th Circuit. District of Kansas
    • February 11, 2002
    ...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
  • Abigail Alliance v. Von Eschenbach, No. 04-5350.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • May 2, 2006
    ...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......
  • Mohr v. TARGETED GENETICS, INC., No. 09-3170.
    • United States
    • United States District Courts. 7th Circuit. United States District Courts. 7th Circuit. Central District of Illinois
    • March 3, 2010
    ...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......
  • Miller v. Pfizer Inc. (Roerig Division), Civil Action No. 99-2326-KHV.
    • United States
    • United States District Courts. 10th Circuit. United States District Courts. 10th Circuit. District of Kansas
    • February 11, 2002
    ...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......
  • Wyeth, Inc. v. Weeks, 1101397.
    • United States
    • Supreme Court of Alabama
    • August 15, 2014
    ...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
  • Pro Te Solutio - Vol. 5 No. 2, March 2012
    • United States
    • JD Supra United States
    • March 30, 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......
  • Annual Review of Federal Securities Regulation - The Business Lawyer, Vol. 70, Iss. 3
    • United States
    • JD Supra United States
    • July 3, 2015
    ...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......
  • Federal Right To Try Legislation – Is It Any Better?
    • United States
    • Mondaq United States
    • September 5, 2017
    ...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......
  • Federal Right To Try Legislation – Is It Any Better?
    • United States
    • LexBlog United States
    • September 5, 2017
    ...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
  • Regulating Clinical Research: Informed Consent, Privacy, and Irbs
    • United States
    • Capital University Law Review Nbr. 31-1, January 2003
    • January 1, 2003
    ...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,......
  • The Drug Approval Process. An Overview
    • United States
    • ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...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......
  • Regulating the research enterprise: international norms and the right to bodily integrity in human experiment litigation.
    • United States
    • Issues in Law & Medicine Vol. 23 Nbr. 2, September 2007
    • September 22, 2007
    ...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......

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