An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three phases. Although in general the phases are conducted sequentially, they may overlap. These three phases of an investigation are a follows:
(a) Phase 1. (1) Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80.
(2) Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.
(b) Phase 2. Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects.
(c) Phase 3. Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually include from several hundred to several thousand subjects.
Notes of Decisions
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
· cites it 2× “21 CFR § 312.21 . After completing the clinical trials, the sponsor files a new drug application containing, inter alia, "full reports of investigations" showing whether the "drug is safe for use and .”
Americans for Safe Access v. Drug Enf't Admin., 706 F.3d 438 (D.C. Cir. 2013).
· cites it 3× “21 C.F.R. 312.21. These studies are designed primarily to explore (Phase II) and to demonstrate or confirm (Phase III) therapeutic efficacy and benefit in patients.”
Kleinman v. Elan Corp., plc, 706 F.3d 145 (2d Cir. 2013).
· cites it 2× “See 21 C.F.R. § 312.21 (a). Phase 2 involves further clinical research and study to determine the drug’s efficacy and any “common short-term side effects and risks associated with the drug.”
Ferretti v. Pfizer Inc., 855 F. Supp. 2d 1017 (N.D. Cal. 2012).
· cites it 5× “Plaintiff alleges that she refused to participate in the PanHER program because the program violated the following federal regulations for Investigational New Drugs (“IND”): 21 C.F.R. §§ 312.21 (a)(1); 312.23(a)(5); 312.”
City of Edinburgh Council as A v. Pfizer Inc, 754 F.3d 159 (3rd Cir. 2014).
· cites it 2× “Phase 2 is a controlled clinical study in which various doses of the drug are tested on groups of up to several hundred patients to evaluate preliminary indicia of the drug’s efficacy and safety.”
Nguyen v. New Link Genetics Corp., 297 F. Supp. 3d 472 (S.D. Ill. 2018).
· cites it 3× “Defendants' specific statement makes clear that Phase 2 showed a "strong efficacy signal " for the high-dose group.”
Brennan v. Zafgen, Inc., 853 F.3d 606 (1st Cir. 2017).
“3d at 39 ; see also 21 C.F.R. § 312.21 . Each phase “requires the company to test the drug on a broader population and results in more stringent monitoring and evaluation.”
Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991).
· cites it 2× “1991); 21 C.F.R. § 312.21 (1990). If the FDA approves the IND, the drug's sponsor may gather data on clinical safety and efficacy needed for a New Drug Application ("NDA"), the formal license application.”
AG Funds, L.P. v. Sanofi, 87 F. Supp. 3d 510 (S.D.N.Y. 2015).
“” 21 C.F.R. § 312.21 (c). Accordingly, this step “can only be taken *534 after there have been positive Phase 2 results sufficient to satisfy both business and regulatory interests.”
— 21 C.F.R. § 312.21(a)(1) — 1 case
Ferretti v. Pfizer Inc., 855 F. Supp. 2d 1017 (N.D. Cal. 2012).
“Plaintiff alleges that she refused to participate in the PanHER program because the program violated the following federal regulations for Investigational New Drugs (“IND”): 21 C.F.R. §§ 312.21 (a)(1); 312.23(a)(5); 312.”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.