FDA policy on unapproved drug products: Past, present, and future

Annals of Pharmacotherapy

Volumn 39, Issue 7-8, 2005, Pages 1260-1264

  Chhabra, Renu ^a   Kremzner, Mary E ^a   Kiliany, Brenda J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Compliance; Drug Efficacy Study Implementation; Food and Drug Administration

Indexed keywords

DRUG APPROVAL; DRUG CONTROL; DRUG MARKETING; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; PRIORITY JOURNAL; REVIEW; WELFARE;

DRUG APPROVAL; DRUG THERAPY; HISTORY, 19TH CENTURY; HISTORY, 20TH CENTURY; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 21744451344     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1E569     Document Type: Review

References (11)

1. Swann JP. The history of drug regulation in the United States (exhibit). Rockville, MD: Food and Drug Administration History Office.
2. Less than effective (LTE) and identical, related and similar (1RS) drugs. Centers for Medicaid and Medicare Services. www.cms.hhs.gov/medicaid/ drugs/drug11.asp (accessed 2004 Sept 3).
3. Marketed unapproved drugs-Compliance Policy Guide [draft guidance]. FDA/CDER; 2003 Oct 15. www.fda.gov/cder/guidance/5704dft.pdf (accessed 2004 Sept 3).
4. Temple RJ. DESI: design history (presentation). Rockville, MD: Food and Drug Administration, October 22, 2003.
5. Office of the Federal Register. 21CFR, part 314.200(e)(5). Washington, DC: US Government Printing Office, 2004. www.access.gpo.gov/cgi-bin/ cfrassemble.cgi?title=200321 (accessed 2004 Sept 3).
6. Horowitz DJ. DESI: current status and unapproved drugs (presentation). Rockville, MD: Food and Drug Administration, October 22, 2003.
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8. Micromedex, Inc. approved drug products and legal requirements. USPDI Volume III. Listing of "Pre-1938" Products. Englewood, CO: World Color Book Services: 1999:III/I.
9. Read DT. DESI: brief legal history (presentation). Rockville, MD: Food and Drug Administration, October 22, 2003.
10. Questions and answers on the Unapproved Drug Compliance Policy Guide: FDA/CDER, 2003 Oct 17. www.fda.gov/cder/compliance/ cpg_qanda.htm (accessed 2004 Sept 3).
11. Marketed Unapproved Drugs-Compliance Policy Guide, www.fda.gov/ cder/guidance/5704dft.pdf (accessed 2004 Sept 3).