Drugs and other product choices

Dermatologic Therapy

Volumn 22, Issue 3, 2009, Pages 216-224

  Hyman, Paul M ^a   Carvajal, Ricardo ^a  

^a Hyman Phelps & McNamara PC   (United States)

Author keywords

Cosmetics; Dietary supplements; Drugs; Medical devices; Medical foods

Indexed keywords

COSMETIC; NON PRESCRIPTION DRUG;

DIET SUPPLEMENTATION; DRUG INFORMATION; DRUG SAFETY; DRUG USE; FOOD AND DRUG ADMINISTRATION; MEDICAL EDUCATION; MEDICAL INFORMATION; MEDICAL INSTRUMENTATION; OFF LABEL DRUG USE; PRESCRIPTION; REVIEW;

COSMETICS; DERMATOLOGIC AGENTS; DERMATOLOGY; DEVICE APPROVAL; DIETARY SUPPLEMENTS; DRUG APPROVAL; EQUIPMENT AND SUPPLIES; HUMANS; SKIN DISEASES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 65549087572     PISSN: 13960296     EISSN: 15298019     Source Type: Journal    
DOI: 10.1111/j.1529-8019.2009.01234.x     Document Type: Review

References (30)

1. Federal Food, Drug, and Cosmetic Act, Public Law No. 75-717, 52 Stat. 1040 (1938).
2. Letter from Secretary of Agriculture, S. Doc No. 75-124 (1937).
3. Federal Food, Drug, and Cosmetic Act, § 505, 21 USC § 355.
4. Federal Food, Drug, and Cosmetic Act, §§ 501-503, 510, 21 USC §§ 351-353, 360.
5. Federal Food, Drug, and Cosmetic Act, §§ 301-304, 704, 21 USC §§ 331-334, 374.
6. Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98-417, 98 Stat. 1585 (1984).
7. Federal Food, Drug, and Cosmetic Act, § 505(j), 21 USC § 355(j).
8. Food and Drug Administration, Guidance for Industry. Applications covered by Section 505(b)(2) (October 1999). http://www.fda.gov/cder/guidance/2853dft. htm. Accessed March 31, 2009.
9. Public Health Service Act, 42 USC § 262.
10. Food and Drug Administration Compliance Policy Guides Manual, § 460.200.
11. Food and Drug Administration Modernization Act, Pub. L. 105-115, § 127, 111 Stat. 2328 (1997).
12. Food and Drug Administration, Guidance for FDA Staff and Industry. Marketed Unapproved Drugs - Compliance Policy Guide, Section 440.100 Marketed New Drugs Without Approved NDAs or ANDAs, 10-11 (June 2006).
13. Food and Drug Administration. Topical drug products containing papain; enforcement action dates. Federal Register 73: 54831, 54832 (September 23, 2008).
14. Federal Food, Drug, and Cosmetic Act, § 503(b)(1), 21 USC § 353(b)(1).
15. Food and Drug Administration. Over-the-counter drugs: proposal establishing rule making procedures for classification. Federal Register 37: 85 (January 5, 1972).
16. Code of Federal Regulations, Title 21, § 330.1.
17. Code of Federal Regulations, Title 21, §§ 333.201-333.350, 347, 350, 358.701.
18. US Food and Drug Administration Compliance Policy Guides Manual, §§ 450.20 and 450.300 (October 1980).
19. Federal Food, Drug, and Cosmetic Act, § 201(h)(3), 21 USC § 321(h)(3).
20. Code of Federal Regulations, Title 21, § 347.3.
21. Federal Food, Drug, and Cosmetic Act, § 513(a)(1)(C), 21 USC § 360c(a)(1)(C).
22. Food and Drug Administration Modernization Act of 1997, Title II, § 206.
23. Federal Food, Drug, and Cosmetic Act, § 201(i), 21 USC § 321(i).
24. Federal Food, Drug, and Cosmetic Act, § 201(g)(1), 21 USC § 321(g)(1).
25. Federal Food, Drug, and Cosmetic Act, § 509, 21 USC § 359.
26. Code of Federal Regulations, Title 21, § 111.
27. Federal Food, Drug, and Cosmetic Act, § 761(b)(1), 21 USC § 379aa-1(b)(1).
28. Federal Food, Drug, and Cosmetic Act, § 201(s), 21 USC § 321(s).
29. Federal Food, Drug, and Cosmetic Act, § 403(r)(6), 21 USC § 343(r)(6).
30. Orphan Drug Act, 21 USC § 360ee(b)(3).