21 C.F.R. §514.12 - Confidentiality of data and information in an investigational new animal drug notice
| Cite as | 21 C.F.R. §514.12 |
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2 practice notes
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Ctr. for Food Safety v. Hamburg, Consolidated Case Nos. 14-cv-04932-YGR
...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 Federal Registe......
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Ctr. for Food Safety v. Hamburg, Consolidated Case No. 14-cv-04932-YGR
...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 Federal Register......
2 cases
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Ctr. for Food Safety v. Hamburg, Consolidated Case Nos. 14-cv-04932-YGR
...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 Federal Registe......
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Ctr. for Food Safety v. Hamburg, Consolidated Case No. 14-cv-04932-YGR
...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 Federal Register......