21 CFR 514.11 - Confidentiality of data and information in a new animal drug application file

Cite as21 CFR 514.11
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398 practice notes
  • Ctr. for Food Safety v. Hamburg, Consolidated Case Nos. 14-cv-04932-YGR
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • November 5, 2015
    ...¶ 3.)Due to statutory and regulatory requirements that applications to FDA for new drugs remain confidential, see 21 U.S.C. § 331(j) ; 21 CFR §§ 514.11, 514.12, plaintiffs only became aware of the approvals, and FDA's associated decision-making, when they were final and published in the Fed......
  • Animal drugs, feeds, and related products: Approved and abbreviated new drug applications; supplements and other changes,
    • United States
    • Federal Register December 13, 2006
    • December 13, 2006
    ...(e.g., trade secret or confidential commercial information) is not disclosed whether it is in a cover letter or an application (see also 21 CFR 514.11). FDA has revised proposed Sec. 514.8(b)(1)(v) to harmonize with the reporting requirements in CDER's regulations Sec. 314.70(a)(6) to only ......
  • Ctr. for Food Safety v. Hamburg, Consolidated Case No. 14-cv-04932-YGR
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • November 5, 2015
    ...¶ 3.) Due to statutory and regulatory requirements that applications to FDA for new drugs remain confidential, see 21 U.S.C. § 331(j); 21 CFR §§ 514.11, 514.12, plaintiffs only became aware of the approvals, and FDA's associated decision-making, when they were final and published in the Fed......
  • Agency information collection activities; proposals, submissions, and approvals,
    • United States
    • Federal Register July 09, 2007
    • July 9, 2007
    ...to support approval of a labeling change. This results in a total of 1,060 burden hours. Freedom of Information Summary (Sec. 514.11 (21 CFR 514.11)). Regulations under Sec. 514.11 require the preparation of a summary of the safety and effectiveness data and information submitted with or in......
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2 cases
  • Ctr. for Food Safety v. Hamburg, Consolidated Case Nos. 14-cv-04932-YGR
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • November 5, 2015
    ...¶ 3.)Due to statutory and regulatory requirements that applications to FDA for new drugs remain confidential, see 21 U.S.C. § 331(j) ; 21 CFR §§ 514.11, 514.12, plaintiffs only became aware of the approvals, and FDA's associated decision-making, when they were final and published in the Fed......
  • Ctr. for Food Safety v. Hamburg, Consolidated Case No. 14-cv-04932-YGR
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • November 5, 2015
    ...¶ 3.) Due to statutory and regulatory requirements that applications to FDA for new drugs remain confidential, see 21 U.S.C. § 331(j); 21 CFR §§ 514.11, 514.12, plaintiffs only became aware of the approvals, and FDA's associated decision-making, when they were final and published in the Fed......

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