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.
- Legal Requirements and Policy for Controlled Substances (PDF - 453KB) - Mark W. Caverly, Chief Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, U.S. Department of Justice
- Opioids, Safety Surveillance, and Risk Management (PDF - 89KB) - Gerald Dal Pan, M.D., MHS Director Office of Surveillance & Epidemiology Center for Drug Evaluation and Research, Food and Drug Administration
- FDA’s Involvement in Preventing Opioid Abuse (PDF - 230KB) - Michael Klein, Ph.D., Director, Controlled Substance Staff, Center for Drug Evaluation and Research, Food and Drug Administration
- Regulatory Issues in Reviewing and Approving Opioid Analgesics (PDF - 4000KB) - Bob A. Rappaport, M.D. Director Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research, Food and Drug Administration
- SAMHSA Initiatives to Educate Prescribers and Consumers and Treatment Resources (PDF -637KB) - Nick Reuter, Division of Pharmacologic Therapy, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration
- How NIDA NIDA’s Initiatives Promotes Understanding of Prescription Opioids (PDF - 1000KB) - Betty Tai, Ph.D., Captain USPHS, Director, Center for the Clinical Trials Network, National Institute on Drug Abuse, National Institutes of Health
- National Association of State Controlled Substances Authorities (NASCSA) (PDF -174KB) - Karen Tannert, President, NASCSA
- CDER Office of Compliance Role in Drug Safety (PDF -300KB) - Jason Woo, M.D., MPH, Associate Director for Scientific and Medical
Affairs, Center for Drug Evaluation and Research, Food and Drug Administration
Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids
Main page for Opioid Drugs and REMS information