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Volumn 36, Issue 2, 2002, Pages 333-341

The United States Food and Drug Administration's risk management framework

Author keywords

Data mining; FDA; MedWatch; Office of Postmarketing Drug Risk Assessment (OPDRA); Peter Honig; Risk management

Indexed keywords

CONFERENCE PAPER; CONSUMER; DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; DRUG SAFETY; DRUG USE; FOOD AND DRUG ADMINISTRATION; HEALTH EDUCATION; MEDICAL INFORMATION; PHILOSOPHY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK ASSESSMENT; RISK MANAGEMENT; STAFF; STANDARD; UNITED STATES;

EID: 0036377812     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150203600212     Document Type: Conference Paper
Times cited : (2)

References (21)
  • 2
    • 0010379906 scopus 로고    scopus 로고
    • Statement by Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, before the Committee on Health, Education, Labor and Pensions, United States Senate, February 1, 2000
    • Statement by Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, before the Committee on Health, Education, Labor and Pensions, United States Senate, February 1, 2000.
  • 3
    • 0034902061 scopus 로고    scopus 로고
    • Risk management of marketed drugs: FDA and the interface with the practice of medicine
    • Uhl K, Honig P. Risk management of marketed drugs: FDA and the interface with the practice of medicine. Pharmacoepidemiology Drug Safety. 2001;10:205-208.
    • (2001) Pharmacoepidemiology Drug Safety , vol.10 , pp. 205-208
    • Uhl, K.1    Honig, P.2
  • 4
    • 0010380170 scopus 로고    scopus 로고
    • Update on the New FDA Office of Postmarketing Drug Risk Assessment (OPDRA)
    • Honig P. Update on the New FDA Office of Postmarketing Drug Risk Assessment (OPDRA). Presented at the Drug Information Association 1999 Annual Meeting. http://www.fda.gov/cder/present/dia-699/opdra2-dia/sld001.htm.
    • Drug Information Association 1999 Annual Meeting
    • Honig, P.1
  • 17
    • 0010379907 scopus 로고    scopus 로고
    • January 3
    • Shiew-Mei Huang, Associate Director for FDA's Office of Clinical Pharmacology and Biopharmaceutics Science and Regulatory Policy. The Pink Sheet. January 3, 2000.
    • (2000) The Pink Sheet
    • Huang, S.-M.1
  • 18
    • 0010414318 scopus 로고    scopus 로고
    • Reference to RAPS Annual Conference Session - Risk Management - Impact on the Consumer
    • October 6
    • Reference to RAPS Annual Conference Session-Risk Management-Impact on the Consumer. Rockville Dispatch. October 6, 2000.
    • (2000) Rockville Dispatch
  • 19
  • 20
    • 0010334442 scopus 로고    scopus 로고
    • Centers for Education and Research on Therapeutics
    • Agency for Health Care Research and Quality. Centers for Education and Research on Therapeutics. http.//www.ahrq.gov/clinic/certsfact.pdf.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.