21 C.F.R. 314.50 - Content and format of an application
| Cite as | 21 C.F.R. 314.50 |
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345 practice notes
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Part II
...Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 314.96 Legal Deadline: None Abstract: The Food and Drug Administration is proposing to amend the regulations......
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Introduction to Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions, 64075-64305 [05-21048]
...Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94 Legal Deadline: None Abstract: The Food and Drug Administration is proposing to amend the regulations governing the ......
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The Regulatory Plan, 72725-72938 [06-8765]
...Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 314.96 Legal Deadline: None Abstract: The Food and Drug Administration is proposing to amend the regulations......
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Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions
...action may affect the private sector under Public Law 104-4. Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR Legal Deadline: None. Abstract: The Food and Drug Administration is proposing to amend the regulations ......
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157 cases
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Kanter v. Warner-Lambert Co., No. A094975.
...study"].) A new drug application must also include "specimens" of the labeling proposed for the drug. (§ 355(b)(1)(F); see 21 C.F.R. §§ 314.50(c)(2)(i) (2001) [application must include proposed text of labeling], 201 et seq. (2001) [general labeling provisions].) If the FDA determines that ......
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O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
...it must provide new supporting data to the FDA, including updated integrated summary of safety ("ISS") and effectiveness ("ISE"). 21 C.F.R. § 314.50(d)(5)(vi)(a). If the FDA finds that any information from a post-approval report or a new ISS report merits a change in the drug's labeling, it......
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Knipe v. Smithkline Beecham, Civil Action No. 06-3024.
...as the Secretary may require; and (f) specimens of the labeling proposed to be used for such drug. 21 U.S.C. § 355(b)(1); see also 21 C.F.R. § 314.50 (setting forth a complete list of requirements for an NDA). The "labeling" requirement for a drug refers not simply to the label attached to ......
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State v. Ortho-Mcneil-Janssen Pharms., Inc., Appellate Case No. 2012-206987
...efficacy, toxicity, and pharmacological properties." Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 196 (2005) (citing 21 C.F.R. § 314.50(d)(2), (5) (2005)).The FDA new drug approval process includes specific procedures through which warning labels are drafted, approved, and requ......
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15 firm's commentaries
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Pro Te Solutio - Vol. 5 No. 3 August 2012
...are relevant to determining the safety and effectiveness of a device, FDA encourages sponsors to collect the data […].” Guidance at 2. 6 21 CFR 314.50 (d)(5)(v) and (vi)(a). 7 Id. 8 Guidance at 3. 9 Guidance at 5. 10 See, e.g., Virk, Karen P., “The Missing Minorities,” Good Clinical Practic......
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Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book
...or container is part of the NDA because the agency does not approve the packaging or container per se. 67 Fed. Reg. at 65,451; see 21 C.F.R. § 314.50(d)(1)(ii)(a). The packaging or container is distinct from the approved drug product and "thus fall[s] outside of the requirements for patent ......
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Wyeth v. Levine’s ‘Clear Evidence' Language: Clearly Misunderstood
...Levine v. Wyeth, 183 Vt. 76, 83 n.1 (2006). [3] 21 U.S.C. §§355(a), 355(b)(1)(F); 21 U.S.C. §331(d). [4] 21 U.S.C. §355(d)(1)-(4), (7); 21 CFR §314.50(c)(2)(i). [5] 21 CFR §314.80(b)-(c); see generally 21 U.S.C. §355(k)(1) (authorizing FDA to require reports of clinical experience with appr......
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New Decisions Raise Old Issues
...by th[at] manufacturer.” Id.Creatively, the plaintiff also tried to gin up a misrepresentation claim based upon an FDA regulation, 21 C.F.R. §314.50(d)(5)(vi)(b) (impressive division into subparts, that), under which (plaintiff claimed) the defendant “voluntarily” became the “Referenced Lis......
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6 books & journal articles
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Notice and Prefiling Considerations
...3, 1994). 14. 21 U.S.C. § 355(b)(1)(G). 15. 21 C.F.R. § 314.53(d)(1). 16. 21 U.S.C. § 355(c)(2). 17. 21 C.F.R. § 314.94(a)(12)(vi); 21 C.F.R. § 314.50 (i)(4); see also Am. Bioscience, Inc., v. Thompson, 269 F.3d 1077 (D.C. Cir. 2001). 18. Apotex, Inc. v. Thompson, 347 F.3d 1335, 1347 (Fed. ......
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Responding to the Complaint
...of Lupin Ltd., the Indian parent company. However, Lupin Pharmaceuticals had cosigned the ANDA as the agent of Lupin Ltd. pursuant to 21 C.F.R. § 314.50(a)(5), which requires that when the entity that signs the ANDA does not have a residence or have a place of business within the United Sta......
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Initiating Litigation
...plaintiff for lack of standing. Id. at 399. 6. 35 U.S.C. § 271(e)(2)(A). 7. 21 C.F.R. §§ 314.3(b) & 314.50(a)(1) & 314.94(a)(1). 8. 21 C.F.R. § 314.50(a)(5). In In re Rosuvastatin Calcium Patent Litigation, the court held that a subsidiary of a foreign ANDA applicant that signs an ANDA and ......
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Drugs' Other Side-Effects
...has nine members and is more restrictive. Id. § 360j(f)(3). 244. Id. § 355(n)(1). 245. Id. § 360c(b). 246. Id. § 360c(b)(2); 21 C.F.R. § 314.50(c)(1) (2018). 247. Comprehensive Addiction and Recovery Act of 2016, Pub. L. No. 114-198, § 106(a)(1)(B)(i), 130 Stat. 695, 702. 248. Human Drug Ad......
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