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21 C.F.R. §514.11 - Confidentiality of data and information in a new animal drug application file

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Cite as21 C.F.R. §514.11
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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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