21 CFR 514.111 - Refusal to approve an application

Cite as21 CFR 514.111
    • This document is available in original version only for vLex customers

      View this document and try vLex for 7 days
    • TRY VLEX
7 practice notes
  • Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...establishment that is not registered. For consistency with current Sec. 314.125(b)(11), we are proposing to revise Sec. 514.111(a)(12) (21 CFR 514.111(a)(12)) for NADAs to state that we will refuse to approve an application if ``the drug will be manufactured in whole or in part in an establ......
  • Part II
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...establishment that is not registered. For consistency with current Sec. 314.125(b)(11), we are proposing to revise Sec. 514.111(a)(12) (21 CFR 514.111(a)(12)) for NADAs to state that we will refuse to approve an application if ``the drug will be manufactured in whole or in part in an establ......
  • Stauber v. Shalala, No. 94-C-0090-C.
    • United States
    • United States District Courts. 7th Circuit. Western District of Wisconsin
    • August 4, 1995
    ...4) whether it is likely that the conditions of use proposed or suggested in the labeling will be followed. 21 U.S.C. § 360b(d)(2); 21 C.F.R. § 514.111(a)(4). The FDA is required to take into account the drug's effect on the health of the target animal. 21 U.S.C. § 321(u). A new drug applica......
  • U.S. v. An Article of Drug Consisting of 4,680 Pails, More or Less, Each Pail Containing 60 Packets, Etc., No. 82-1381
    • United States
    • United States Courts of Appeals. United States Court of Appeals (5th Circuit)
    • February 27, 1984
    ...studies. For example, the regulation requires certain standards for "[t]he method of selection of the animals to be studied ...." 21 C.F.R. Sec. 514.111(a)(5)(ii) (1983) (emphasis added). Since Pfizer has wholly failed to provide any adequate and well-controlled studies that compare the eff......
  • Request a trial to view additional results
5 cases
  • Stauber v. Shalala, No. 94-C-0090-C.
    • United States
    • United States District Courts. 7th Circuit. Western District of Wisconsin
    • August 4, 1995
    ...4) whether it is likely that the conditions of use proposed or suggested in the labeling will be followed. 21 U.S.C. § 360b(d)(2); 21 C.F.R. § 514.111(a)(4). The FDA is required to take into account the drug's effect on the health of the target animal. 21 U.S.C. § 321(u). A new drug applica......
  • U.S. v. An Article of Drug Consisting of 4,680 Pails, More or Less, Each Pail Containing 60 Packets, Etc., No. 82-1381
    • United States
    • United States Courts of Appeals. United States Court of Appeals (5th Circuit)
    • February 27, 1984
    ...studies. For example, the regulation requires certain standards for "[t]he method of selection of the animals to be studied ...." 21 C.F.R. Sec. 514.111(a)(5)(ii) (1983) (emphasis added). Since Pfizer has wholly failed to provide any adequate and well-controlled studies that compare the eff......
  • American Cyanamid Co. v. Food and Drug Administration, No. 77-1969
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • August 23, 1979
    ...the raw data are available in the application. Cyanamid submitted such tests. See notes 57-158 Infra and accompanying text. See also 21 C.F.R. § 514.111 (1978) (essentially reiterating the demands of § 512(d), quoted in text at note 14 Supra, with respect to safety tests). Nor do counsel fo......
  • Masti-Kure Products Co., Inc. v. Califano, MASTI-KURE
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • June 16, 1978
    ...of the methods of analysis and an evaluation of data derived from the study, including any appropriate statistical methods." Compare 21 C.F.R. § 514.111(a)(5)(iv) (1977), Supra note 2. The Court stated that "(a) mere reading of the study submitted will indicate whether the study is totally ......
  • Request a trial to view additional results

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT