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美国FDA药品不良反应监测体系简介 被引量:20

Brief introduction of the ADR Supervision System of FDA
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摘要 本文对美国FDA的药品不良反应监测体系进行研究 ,介绍了FDA在ADR监测中的作用和采取的ADR风险控制措施 ,以及FDA对未来ADR监测体系的改进计划 。 In this paper,authors reviewed the ADR Supervision System of FDA,USA,introduced the role of FDA in ADR supervision and the control measures adopted by FDA and the future plan that will be implemented by FDA It may probably give some reference to supervision and administrative department and medical workers in China.
出处 《中国工业医学杂志》 CAS 北大核心 2003年第5期305-307,共3页 Chinese Journal of Industrial Medicine
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参考文献6

  • 1FDA.How to report drug shortages, Medwatch [DB/OL] .www. fda.gov.
  • 2FDA/CDER (Center for drug evaluation and research), FDA product recalls, Allerts and warnings [DB/OL]. www. fda. gov.
  • 3FDA.Federal Food, Drug and Cosmetic Act, portions revised or new as amended by the FDA modernization Act of 1997 [ DB/OL]. www.fda. gov.
  • 4FDA/CDER.Drug shortages [ DB/OL]. www. fda. gov/cder/drug/shortages, June 2002.
  • 5FDA/CDER.FDA's role in responding to drug shortages[ EB]. Am J Health Pharm, 2002, 59: 1423-1425.
  • 6ASHP guidelines on managing drug product shortages [J]. Am J Health Pharm, 2001, 58: 1445-1450.

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