Source: http://www.annalsofhealthlaw.com/annalsofhealthlaw/vol_22_issue_3?pg=46
Timestamp: 2019-04-18 10:43:24+00:00

Document:
drug—even if true—without the approval of the FDA.
18. 21 U.S. C. § 321(m) (2009).
19. 21 U.S. C. § 321(k) (2009).
20. See 21 C.F.R. § 208.1 (1998); 21 C.F.R. 208.20 (2008); 21 C.F.R. 202.1 (1998).
21. Girard, supra note 10, at 123.
22. John E. Osborn, Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information, 10 YALE J. HEALTH POL’Y L. & ETHICS 299, 308 (2010). See also Kordel v. United States, 335 U.S. 345, 350 (1948) (defining literature that “accompanies” drugs).
23. 21 U.S. C. §§ 331(a), (b) (2013); 21 U.S. C. § 352(a) (2012).
24. 21 U.S. C. §§ 352 (f) and (a) (defining “inadequate directions for use” and “false and misleading label,” respectively).
25. 21 U.S. C. §§ 352 (f) and (a).
26. 21 C.F.R. § 201.128 (2012).

References: § 321
 § 321
 § 208
 v. 
 § 352
 § 201