21 C.F.R. §312.21 - Phases of an investigation
| Cite as | 21 C.F.R. §312.21 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
6 firm's commentaries
-
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......
-
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......
-
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......
-
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......
Request a trial to view additional results
4 books & journal articles
-
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,......
-
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......
-
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......
-
Germline Editing Using CRISPR: Why a Moratorium Is Not the Solution (From the 2020 Schwab Family Law Essay Contest)
...-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......