21 C.F.R. §312.3 - Definitions and interpretations

Cite as21 C.F.R. §312.3
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13 cases
  • Elan Corp., Plc v. Andrx Pharmaceuticals, Inc., 98-7164-CIV.
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • 14 Marzo 2002
    ...any such product. See Elan's Proposed Findings of Fact and Conclusions of Law ¶ 215 (citing 21 U.S.C. § 355(a), (i); 21 C.F.R. §§ 312.2, 312.3, 312.7, 312.20-.38). Moreover, Syntex Corporation owned U.S.Patent No. 3,998,966 for naproxen, the active ingredient in Naprelan®, and this patent d......
  • US v. Najarian, Cr. No. 3-95-45.
    • United States
    • United States District Courts. 8th Circuit. United States District Court of Minnesota
    • 12 Enero 1996
    ...applicable Regulations do allow for a "sponsor-investigator" who bears the administrative burdens attendant to both positions. See, 21 C.F.R. § 312.3(b). 21 Given the fact that the terms "adverse experiences" and "serious adverse experiences," and the requisites of "informed consent" are de......
  • Abigail Alliance for Better Access v. Von Eschenbach, 04-5350.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 7 Agosto 2007
    ...Notes: 1. In FDA parlance, experimental drugs that have not yet been approved for public use are deemed "investigational drug[s]." See 21 C.F.R. § 312.3(b). 2. In some circumstances, a Phase IV review is conducted, which "delineate[s] additional information about the drug's risks, benefits,......
  • In re Ohio Execution Protocol Litig., Case No. 2:11-cv-1016
    • United States
    • United States District Courts. 6th Circuit. United States District Courts. 6th Circuit. Southern District of Ohio
    • 12 Julio 2017
    ...purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice." 21 C.F.R. § 312.3(b).1268. Defendants' Execution Protocol's experimental use of pentobarbital, thiopental sodium, or midazolam followed by a paralytic drug and......
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