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U.S. Department of Health and Human Services

Drugs

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February 10, 2009 Stakeholders Meeting: Information and Presentations

  

FDA Regulatory Process and Standards for Review and Approval of Opioid Analgesics; An Educational Primer and Conversation

On February 10, 2009, FDA’s Office of Special Health Issues and the Center for Drug Evaluation and Research (CDER) held a stakeholders meeting entitled, “FDA Regulatory Process and Standards for Review and Approval of Opioid Analgesics; An Educational Primer and Conversation.”  The Drug Enforcement Administration, the National Institute on Drug Abuse, the Substance Abuse and Mental Health Services Administration, and the National Association of State Controlled Substance Authorities also participated.  The goals of this meeting were:

  • To discuss regulatory process and standards for review and approval of opioid analgesics.
  • To discuss FDA’s limitations in authority for regulating opioid drug products and balancing the needs of diverse groups.
  • To provide an opportunity for FDA to hear perspectives regarding abuse prevention and pain management from various constituencies and other government agency staff.

Agenda (PDF - 22KB)

Participant List (PDF - 109KB)

Meeting Summary (PDF - 88KB)

Presentations

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Related Information

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