Trying times at the FDA - The challenge of ensuring the safety of imported pharmaceuticals

New England Journal of Medicine

Volumn 358, Issue 17, 2008, Pages

  Schweitzer, Stuart O ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEPARIN; ROFECOXIB;

COURT; DEVICE; DRUG APPROVAL; DRUG HYPERSENSITIVITY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG MONITORING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HUMAN; PHARMACEUTICAL CARE; PRIORITY JOURNAL; SHORT SURVEY;

EID: 42549153466     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp0802041     Document Type: Article

References (5)

1. Bogdanich W. Blood thinner might be tied to more deaths. New York Times. February 29, 2008.
2. Idem. Heparin find may point to Chinese counterfeiting. New York Times. March 20, 2008.
3. Drug safety - preliminary findings suggest weakness in FDA's program for inspecting foreign drug manufacturers. Testimony of Marcia Crosse, director health care, before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives, November 1, 2007. Washington, DC: Government Accountability Office. (GAO-08-224T.) (Accessed April 4, 2008, at http://www.gao.gov/htext/d08224t.html.)
4. Risk-based method for prioritizing CGMP inspections of pharmaceutical manufacturing sites - a pilot risk ranking model. Rockville, MD: Food and Drug Administration, September 2004. (Accessed April 4, 2008, at http://www.fda.gov/ cder/gmp/gmp2004/risk_based.pdf.)
5. Barnes K. US and EU pharma trade bodies slam poor regulation of foreign APIs. LabTechnologist.com, October 20, 2006.