21 C.F.R. 314.105 - Approval of an NDA and an ANDA
| Cite as | 21 C.F.R. 314.105 |
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114 practice notes
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Sita v. Danek Medical, Inc., No. Civ.A. 95-3630(DGT).
...to ensure that drugs meet certain statutory standards for safety and effectiveness, manufacturing and controls, and labeling, 21 C.F.R. § 314.105(c) (1993), and to ensure that manufacturers market their drugs only for those indications for which the drug sponsor has demonstrated "substantia......
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Mylan Laboratories, Inc. v. Thompson, No. CIV.A.04-1049(RBW).
...on the date the agency issues a letter approving the drug, "unless the approval letter provides for a delayed effective date." 21 C.F.R. § 314.105(d). Page If there is a delayed effective date, the FDA considers the approval "tentative and [it] does not become final until the effective date......
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O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
...(prescribing information) that is identical, in every material respect, to the labeling that accompanies the approval letter. 21 C.F.R. § 314.105(b). Use of the FDA-approved prescribing information is mandatory and failure to comply may lead to civil and criminal enforcement. The FDCA envis......
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Knipe v. Smithkline Beecham, Civil Action No. 06-3024.
...and send the applicant an approval letter if none of the[se] reasons ... for refusing to approve the application applies." 21 C.F.R. § 314.105(a). The FDA "will approve an application and issue the applicant an approval letter ... on the basis of draft labeling if the only deficiencies in t......
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108 cases
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Sita v. Danek Medical, Inc., No. Civ.A. 95-3630(DGT).
...to ensure that drugs meet certain statutory standards for safety and effectiveness, manufacturing and controls, and labeling, 21 C.F.R. § 314.105(c) (1993), and to ensure that manufacturers market their drugs only for those indications for which the drug sponsor has demonstrated "substantia......
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Mylan Laboratories, Inc. v. Thompson, No. CIV.A.04-1049(RBW).
...on the date the agency issues a letter approving the drug, "unless the approval letter provides for a delayed effective date." 21 C.F.R. § 314.105(d). Page If there is a delayed effective date, the FDA considers the approval "tentative and [it] does not become final until the effective date......
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O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
...(prescribing information) that is identical, in every material respect, to the labeling that accompanies the approval letter. 21 C.F.R. § 314.105(b). Use of the FDA-approved prescribing information is mandatory and failure to comply may lead to civil and criminal enforcement. The FDCA envis......
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Pennsylvania Employees Ben. Trust v. Zeneca, No. 05-5340.
...determines that the drug meets the statutory standards for safety and effectiveness, manufacturing and controls, and labeling.. . ." 21 C.F.R. § 314.105(c) (emphasis added). The Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301, et seq., requires that applicants for new drug applicatio......
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5 firm's commentaries
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Can A State Impose Civil Penalties On A Drug Or Device Company For Using A Federally-Approved Label?
...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. §314.105(c). 11 21 C.F.R. §314.105(b) (“[A]pproval will be conditioned upon the applicant incorporating the specified labeling changes exactly as dir......
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Can A State Impose Civil Penalties On A Drug Or Device Company For Using A Federally-Approved Label?
...21 C.F.R. §314.50(d)(5)(viii). See 21 C.F.R. §314.125(b)(2), (3), (4), (6). 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 upon the applicant incorporating the specified labeling changes exactly as directed, and upo......
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Litigation Alert: The Supreme Court Upholds a Jury Verdict against Wyeth Based on a Failure-to-Warn Theory
...hosted at http://www.jdsupra.com/post/documentViewer.aspx?fid=3f9efafb-3b2c-4720-a8b8-7dc1cd00a9dbEndnotes 1 21 U.S.C. § 301 et seq. 2 21 CFR § 314.105(b) 3 21 CFR §§ 314.70(c)(6)(iii)(A),(C) For assistance in this area, please contact one of the attorneys listed below or any member of your......
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First Impressions of the Defense Position – Wyeth v. Levine
...is “conditioned upon” the manufacturer using the labeling approved by the FDA “exactly as directed” by the Agency. Br. at 30 (quoting 21 C.F.R. §314.105(b)). The plaintiff’s verdict is based upon the theory that the FDA approved use should be contraindicated – that is, never allowed under a......
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2 books & journal articles
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Examining Subject-Matter Jurisdiction over Declaratory Judgment Claims Filed in Combination with Patent Infringement Claims under Section 271(e)(2)(A)
...1992). 22. Abbott Labs., 934 F. Supp. at 938–39. 23. Id. 24. Id. at 939. 25. Id. at 938. FDA approval of ANDAs is governed pursuant to 21 C.F.R. § 314.105. 26. dor54588_08_ch08_149-174.indd 153 5/5/16 5:35 PM 154 CHAPTER 8 It makes little sense, and thus we assume would be inconsistent with......
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Too good to last? Will the FDA's proposed rule put an end to generic drug preemption under Mensing and Bartlett?
...warning label. (27) Wyeth relied on federal statues, 21 U.S.C. [section] 355, and FDA regulations implementing such statutes, 21 C.F.R. 314.105(b). (28) The Supreme Court disagreed, relying on the CBE process, just as the courts below had done: There is, however, an FDA regulation that perm......