Pharmaceutical postmarket review: Fact or fiction?

Food and Drug Law Journal

Volumn 62, Issue 3, 2007, Pages 493-500

  Schanz, Stephen J ^a  

^a NORTH CAROLINA STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

COST; DECISION MAKING; DRUG APPROVAL; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; LAW; LAW SUIT; POLICY; POSTMARKETING SURVEILLANCE; REVIEW; UNITED STATES; UNSPECIFIED SIDE EFFECT; ARTICLE; DRUG LEGISLATION; LEGAL ASPECT; METHODOLOGY;

DRUG APPROVAL; DRUG INDUSTRY; HUMANS; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 35549010743     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (40)

1. 21 C.F.R. § 314.80 (2006).
2. Justin Blum & Jeffrey Tannenbaum, Drugmakers Fail To Do Post-Approval Studies in U.S., (Mar. 3, 2006), http://www.bloomberg.com/ apps/news?pid=newsarchive&sid=a8BjDILnn2kA.
3. 21 U.S.C. § 356b (2006).
4. Id.
5. 21 C.F.R. § 314.81(b) (2) (2006).
6. Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies, 69 Fed. Reg., 12163 (Mar. 15, 2004).
7. 21 U.S.C. § 356b(b) (2006).
8. Id. § 356b(d).
9. Id. § 356b(e).
10. Id. § 356b(2)(A).
11. 21 C.F.R. §§ 314.610(b)(1), 601.91(b)(1) (2006).
12. 21 U.S.C. § 355b(b) (2006).
13. Id. § 355(k)(1).
14. Guidance for Industry, Reports on Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Modernization Act of 1997 (Feb. 15, 2006), http://www.fda. gov/cder/guidance/5569fnl.htm.
15. 21 C.F.R. § 312.21(a)(pertaining to Phase 1), 21 C.F.R. § 312.21(b)(pertaming to Phase 2) and 21 C.F.R. 312.21(c)(pertaining to Phase 3) (2006).
16. Hugh B. Wellons & Eileen Smith Ewing, BIOTECHNOLOGY & THE LAW, 602-603 (2007).
17. Report on the Performance of Drug and Biologics firms in Conducting Postmarketing Commitment Studies: Availability, 72: Fed. Reg. 5069 (Feb. 2 2007).
18. Food and Drug Modernization Act of 1997 Pub. L. No. 105-115, 111 Stat. 2296.
19. Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commit ment Studies: Availability, 72 Fed. Reg. 5069 (Feb. 2, 2007).
20. IOM, The Future of Drug Safety (2006).
21. IOM, The Future of Drug Safety, ix (2006).
22. Id. at 55.
23. Id. at, 155.
24. Id. at 111.
25. Id. at 49.
26. HHS OIG, FDA's Monitoring of Postmarking Study Commitments (2006).
27. IOM, The Future of Drug Safety, 156-157 (2006).
28. Id. at 156.
29. Id. at 164-165.
30. Id. at 165.
31. Id. at 33.
32. Id. at 156.
33. Justin Blum & Jeffrey Tannenbaum, Drugmakers Fail To Do Post-Approval Studies in U.S., (Mar. 3, 2006), http://www.bloomberg.com/ apps/news?pid=newsarchive&sid=a8BjDILnn2kA.
34. IOM, The Future of Drug Safety, 169 (2006).
35. Id. at 170.
36. Id. at 157.
37. Enhancing Drug Safety and Innovation Act of 2007, S. 484, 110th Cong. (2007).
38. Id. § 101(4)(D).
39. Id. § 101(4)(E).
40. 21 C.F.R. § 314.81(2)(i).