21 CFR 514.11 - Confidentiality of data and information in a new animal drug application file
| Cite as | 21 CFR 514.11 |
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398 practice notes
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Ctr. for Food Safety v. Hamburg, Consolidated Case Nos. 14-cv-04932-YGR
...¶ 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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Animal drugs, feeds, and related products:
Approved and abbreviated new drug applications; supplements and other changes,
...(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 ......
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Ctr. for Food Safety v. Hamburg, Consolidated Case No. 14-cv-04932-YGR
...¶ 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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Agency information collection activities; proposals, submissions, and approvals,
...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
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Ctr. for Food Safety v. Hamburg, Consolidated Case Nos. 14-cv-04932-YGR
...¶ 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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Ctr. for Food Safety v. Hamburg, Consolidated Case No. 14-cv-04932-YGR
...¶ 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......