21 C.F.R. §202.1 - Prescription-drug advertisements
| Cite as | 21 C.F.R. §202.1 |
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8 books & journal articles
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The More Things Change: Improvement Patents, Drug Modifications, and the FDA
...as well. See 31 U.S.C. § 3729; Universal Health Servs., Inc. v. United States ex rel . Escobar, 136 S. Ct. 1989, 2003–04 (2016) . 318. 21 C.F.R. § 202.1(e)(6)(ii) (2018); see also id. § 201.57(c)(2)(iii) (“Any statements [on product labeling] comparing the safety or effectiveness of the dru......
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Market Participants and Competition
...abeling. 265. 21 U.S.C. § 321(m). 266. See FDA GLOSSARY, supra note 264; 21 U.S.C. § 321(m). 267. See 21 C.F.R. § 202.1(e)(5)(ii). 268. 21 C.F.R. § 202.1(e). 269. 21 C.F.R. § 201.56. 270. 21 C.F.R. § 202.1. permitted unless supported by substantial evidence or substantial clinical experienc......
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Statins and Adverse Cardiovascular Events in Moderate‐Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims
...Promoting andProtecting the Public Health 159 (Alina Baciu, Kathleen Stratton & Sheila P. Burke eds., 2007)(citing five studies).6821 C.F.R. § 202.1(e)(6). Misleading advertising is deemed to cause a drug to be misbrandedunder the FDCA. Id., § 202.1(k). Introduction or delivery for introduct......
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Influencers: What Every Brand and Legal Counsel Should Know
...LetterstoPharmaceuticalCompanies/UCM457961.pdf. 17. 21 U.S.C. §§ 321(n), 331(a), 352(a), (n); see 21 C.F.R. § 202.1(e)(5). 18. See FAQs, supra note 4. 19. See id. Published in Landslide® magazine, Volume 11, Number 1, a publication of the ABA Section of Intellectual Property Law (ABA-IPL), ......
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