21 C.F.R. §312.21 - Phases of an investigation

Cite as21 C.F.R. §312.21
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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
    • 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......
  • 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......
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4 books & journal articles
  • Regulating Clinical Research: Informed Consent, Privacy, and Irbs
    • United States
    • Capital University Law Review No. 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
    • ABA General Library 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 No. 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......
  • Germline Editing Using CRISPR: Why a Moratorium Is Not the Solution (From the 2020 Schwab Family Law Essay Contest)
    • United States
    • ABA General Library Family Law Quarterly No. 55-1, April 2020
    • April 1, 2020
    ...-inds-cber-regulated-products. 42. 21 C.F.R. § 312.21. 43. The language first appeared in the Consolidated Appropriations Act of 2016, Pub. L. No. 114–113, § 749, 129 Stat. 2242, 2283 (2015), and has been renewed yearly. As to federally funding experimental research, although the NIH Guidel......

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