Source: http://www.annalsofhealthlaw.com/annalsofhealthlaw/vol_22_issue_3?pg=45
Timestamp: 2019-04-18 21:06:09+00:00

Document:
potential off-label uses of its approved drugs.
10. Vicki Girard, Punishing Pharmaceutical Companies for Unlawful Promotion of Approved Drugs: Why the False Claims Act Is the Wrong Rx, 12 J. HEALTH CARE L. & POL’Y 119, 130 (2009).
11. Federal Food, Drug, and Cosmetic Act, 21 U.S. C. §§ 301-399 (2006).
12. 21 U.S. C. §§ 352(a), 352(n), 393(a)-(d) (2006).
13. 21 U.S. C. A. § 331; 21 C.F.R. Pt. 314.
14. 21 U.S. C. § 355; 21 C.F.R. § 201.100(d); 21 U.S. C. § 352(a).
15. 21 U.S. C. § 321(p) (2006) (emphasis added).
16. 21 C.F.R. § 310.3 (1999).

References: § 331
 § 355
 § 201
 § 352
 § 321
 § 310