Source: http://www.annalsofhealthlaw.com/annalsofhealthlaw/vol_22_issue_3?pg=47
Timestamp: 2019-04-18 20:46:17+00:00

Document:
28. Osborn, supra note 22, at 309.
29. Id. at 310; see also Allison D. Burroughs, et al., Off-Label Promotion: Government Theories of Prosecution and Facts that Drive Them, 65 FOOD & DRUG L. J. 555, 563 (setting forth an untested but clear argument regarding why drugs should be exempt from the “adequate directions for use” provision of the misbranding statute).
30. E.g., United States v. An Article of Drug Consisting of 47 Bottles, More or Less, Jenesol RJ Formula ‘60’, 320 F.2d 564, 571 (3d Cir. 1963); Colusa Remedy Co. v. United States, 176 F.2d 554, 561 (8th Cir. 1949).
31. United States v. Sene X Eleemosynary Corp., 479 F. Supp. 970, 980 (S.D. Fla. 1979).
32. 21 U.S. C. § 331 (2012).
33. United States v. Mitcheltree, 940 F.2d 1329, 1351 (10th Cir. 1991).
35. U.S. ex rel. Franklin v. Parke-Davis, 147 F. Supp. 2d 39, 52 (D. Mass. 2001).

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