21 C.F.R. §312.3 - Definitions and interpretations
| Cite as | 21 C.F.R. §312.3 |
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13 cases
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Elan Corp., Plc v. Andrx Pharmaceuticals, Inc., 98-7164-CIV.
...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......
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US v. Najarian, Cr. No. 3-95-45.
...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......
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Abigail Alliance for Better Access v. Von Eschenbach, 04-5350.
...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,......
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In re Ohio Execution Protocol Litig., Case No. 2:11-cv-1016
...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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6 firm's commentaries
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FDA Releases Proposed Rules On National Licensure Standards For Wholesale Drug Distributors And Third-Party Logistics Providers (3PLs)
...of wholesale distribution "the sale or transfer of a drug for investigational or research purposes to an investigator, as defined in 21 CFR 312.3 (or any successor regulation), under investigational new drug application (IND) submitted to FDA." FDA reasoned that distribution of drugs under ......
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FDA Releases Proposed Rules On National Licensure Standards For Wholesale Drug Distributors And Third-Party Logistics Providers (3PLs)
...of wholesale distribution "the sale or transfer of a drug for investigational or research purposes to an investigator, as defined in 21 CFR 312.3 (or any successor regulation), under investigational new drug application (IND) submitted to FDA." FDA reasoned that distribution of drugs under ......
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Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud
...contract research organizations, and the companies who use them. [i] See 21 C.F.R. § 50.3(e) [ii] See 21 C.F.R. § 50.3(d) [iii] See 21 C.F.R. § 312.3(b) [iv] See FDA guidance at
- CMS Issues Proposed Regulations on New Disclosure and Reporting Requirements Related to Manufacturers and GPOs
...will in some cases be duplicative of the requirements under FDA regulations at 21 CFR part 54. See 42 CFR at 78750. 27 CRO as defined by 21 CFR 312.3(b). 28 See 42 CFR at 78749. 29 See id. 30 See id. 5 CMS Issues Proposed Regulations on New Disclosure and Reporting Requirements Related to M......Request a trial to view additional results - CMS Issues Proposed Regulations on New Disclosure and Reporting Requirements Related to Manufacturers and GPOs
7 provisions
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SB 284 – Modifies the disciplinary authority of the Board of Pharmacy, defines the term legend drug for the purpose of certain pharmacy statutes, and grants exemption from sales tax for certain medical equipment and drugs
...only; and(d) The term "drug", "prescription drug", or "legend drug" shall not include:a. An investigational new drug, as defined by 21 CFR 312.3(b), that is being utilized for the purposes of conducting a clinical investigation of that drug or product that is governed by, and being conducte......
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Chapter 1, HB 3001 – Utah Medical Cannabis Act
...in 21 C.F.R. Part 812.[(7)] (4) "Investigational drug" means a drug that:(a) meets the definition of "investigational new drug" in 21 C.F.R. Sec. 312.3; and(b) has successfully completed the United States Food and Drug Administration Phase 1 testing for an investigational new drug described......
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HB 412 – Changes the laws regarding pharmacies
...only; and(d) The term "drug", "prescription drug", or"legend drug" shall not include:a. An investigational new drug, as defined by 21 CFR 312.3(b), thatis being utilized for the purposes of conducting a clinicalinvestigation of that drug or product that is governed by, andbeing conducted pu......
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HB 1719 – Modifies provisions relating to professional registration
...only; and(b) The term "drug", "prescription drug", or "legend drug" shall not include:a. An investigational new drug, as defined by 21 CFR 312.3(b), that is being utilized for the purposes of conducting a clinical trial or investigation of such drug or product that is governed by, and being......
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