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FDA Formulates Drug Safety Plan

• Sponsor an Institute of Medicine study of the drug safety system.
  
• Implement a program for adjudicating differences of professional opinion.
  
• Appoint a director for the FDA Office of Drug Safety.
  
• Conduct drug safety/risk management consultations.
  
• Publish risk management guidances.
  

Below are the names and Web sites of the three draft guidances that the FDA issued in May to help pharmaceutical companies identify and assess potential safety risks before and after a drug reaches the market.

• Premarketing Risk Assessment: www.fda.gov/cder/guidance/5765dft.doc
  
• Development and Use of Risk Minimization Action Plans: www.fda.gov/cder/guidance/5766dft.htm
  
• Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment: www.fda.gov/cber/gdlns/pharmacovig.pdf
  

Related Article:

FDA Vows to Improve Drug-Safety Assessments

Jim Rosack
Psychiatr News 2004 39: 1-43. [Full Text]

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