21 C.F.R. 314.125 - Refusal to approve an NDA

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48 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
    ...In addition, marketing application approval is linked to registration elsewhere in our regulations. Under current Sec. 314.125(b)(11) (21 CFR 314.125(b)(11)), we may refuse to approve an application if the drug will be manufactured or processed in an establishment that is not registered. Fo......
  • Human drugs and biological products: Prescription drug products; labeling requirements,
    • United States
    • Federal Register January 24, 2006
    • January 24, 2006
    ...Section 701(a) of the act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the efficient enforcement of the act. Under 21 CFR 314.125, FDA will not approve an NDA unless, among other things, there is adequate safety and effectiveness information for the labeled uses and the produc......
  • Part II
    • United States
    • Federal Register January 24, 2006
    • January 24, 2006
    ...Section 701(a) of the act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the efficient enforcement of the act. Under 21 CFR 314.125, FDA will not approve an NDA unless, among other things, there is adequate safety and effectiveness information for the labeled uses and the produc......
  • Part II
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...In addition, marketing application approval is linked to registration elsewhere in our regulations. Under current Sec. 314.125(b)(11) (21 CFR 314.125(b)(11)), we may refuse to approve an application if the drug will be manufactured or processed in an establishment that is not registered. Fo......
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31 cases
  • Gremo v. Bayer Corp., 1:19-cv-13432-NLH-AMD
    • United States
    • U.S. District Court — District of New Jersey
    • June 29, 2020
    ...with the FDA to develop an appropriate label when they apply for FDA approval of a new drug. 21 U.S.C. §§ 355(a), 355(b), 355(d)(7) ; 21 C.F.R. § 314.125(b)(6). But FDA regulations also acknowledge that information about drug safety may change over time, and that new information may require......
  • Kanter v. Warner-Lambert Co., No. A094975.
    • United States
    • California Court of Appeals
    • June 25, 2002
    ...of a material fact, or if the proposed labeling does not comply with the requirements established in the regulations. (§ 355(d)(7); 21 C.F.R. § 314.125(b)(6), (7), (8) After a new drug application has been approved, any change in the labeling requires a supplement to an application and appr......
  • O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • January 30, 2008
    ...use under the conditions provided in the proposed labeling; or (3) the proposed labeling is false and misleading. 21 U.S.C. § 355(d); 21 C.F.R. § 314.125(b)(2), (3), As part of the approval process, manufacturers of new drugs submit to the FDA "specimens of the labeling proposed to be used ......
  • Pennsylvania Employees Ben. Trust v. Zeneca, No. 05-5340.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • August 17, 2007
    ...The FDA may refuse to approve an application on the grounds that "[t]he proposed labeling is false or misleading in any particular." 21 C.F.R. § 314.125(b)(6). Thus, to the extent that the advertising statements regarding Nexium were consistent with statements used in the labeling approved ......
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5 firm's commentaries
  • Striking Back at Strike Suits
    • United States
    • LexBlog United States
    • June 28, 2007
    ...included in the labeling of a new drug reflects a determination by the FDA that the information is not “false or misleading.” [citing 21 C.F.R. §314.125(b)(6)]. Thus, even if the advertisements did not comport precisely with [the drug’s] approved label by claiming that [it] reduces the risk......
  • Can A State Impose Civil Penalties On A Drug Or Device Company For Using A Federally-Approved Label?
    • United States
    • Mondaq United States
    • November 5, 2013
    ...for violations of the FDCA) . 21 U.S.C. §355(a)-(b). 21 U.S.C. §355(b)(1)(F). Id. §355(b)(1)(A) 21 C.F.R. §314.50(d)(5)(viii). See 21 C.F.R. §314.125(b)(2), (3), (4), 21 U.S.C. §321(n). 21 C.F.R. §314.125(b)(7). 21 C.F.R. §314.105(c). 21 C.F.R. §314.105(b) ("[A]pproval will be conditioned u......
  • Can A State Impose Civil Penalties On A Drug Or Device Company For Using A Federally-Approved Label?
    • United States
    • JD Supra United States
    • October 31, 2013
    ...5 Id. §355(b)(1)(A) 6 21 C.F.R. §314.50(d)(5)(viii). 7 See 21 C.F.R. §314.125(b)(2), (3), (4), (6). 8 21 U.S.C. §321(n). 9 21 C.F.R. §314.125(b)(7). 10 21 C.F.R. 11 21 C.F.R. §314.105(b) (“[A]pproval will be conditioned upon the applicant incorporating the specified labeling changes exactly......
  • Status of U.S. Biosimilar Approvals and Pending Applications*
    • United States
    • JD Supra United States
    • June 29, 2018
    ...of them have received Complete Response Letters from the FDA (indicating that the agency will not approve the application under 21 C.F.R. §§ 314.125 or 314.127), and many have been pending longer than the 10-20 month average experienced by the already-approved Biosimilar litigation is also ......
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1 books & journal articles
  • The Drug Approval Process. An Overview
    • United States
    • ANDA litigation: strategies and tactics for pharmaceutical patent litigators
    • June 2, 2016
    ...An NDA, however, is not officially “filed” until the FDA determines that the application contents are “approvable.” Id.; see 21 C.F.R. § 314.125(b). If the NDA is missing information, the FDA is not obligated to begin the review until the drug sponsor provides the required information. Zele......

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