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Food and Drug Administration Please note the agenda times listed are subject to change as the meeting progresses
September 9, 2003 |
| 8:00 a.m. |
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Call to Order and Opening
Remarks Introduction of Committee Conflict of Interest (COI) Statement |
| 8:15 a.m. |
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Opening Remarks Risk Management of Opiate Analgesics |
| 8:30 a.m. |
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FDA's Role in the Risk
Management of Opiate Analgesics |
| 8:45 a.m. |
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The Controlled Substances
Act and Sponsor Presentation Risk Management |
| 9:00 a.m. |
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The Drug Enforcement
Agency's Role in Risk Management of Opiate Analgesics |
| 9:15 a.m. |
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Review of Current Medical
Practice, Clinical Use and Benefit of Opiate Analgesic Treatment |
| 9:45 a.m. |
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Break |
| 10:00 a.m. |
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Opiate Use Data |
| 10:15 a.m. |
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Misuse and Abuse of Opiate
Analgesics in the Medical Setting |
| 10:45 a.m. | Opiate Abuse Data |
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| 11:45 a.m. | Prescription Opiate
Diversion |
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| 12:15 p.m. | Lunch |
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| 1:15 p.m. | Open Public Hearing Existing Risk Management Plans |
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| 2:15 p.m. | Goals of Risk Management
Plans/Non-Opiate Risk Management Plans |
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| 2:45 p.m. | Break |
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| 3:00 p.m. | Current Opioid Risk
Management Plans |
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| 3:30 p.m. | Committee Discussion |
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| 5:00 p.m. |
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Adjournment |
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Food and Drug Administration Please note the agenda times listed are subject to change as the meeting progresses September 10, 2003
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| 8:00 a.m. |
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Call to Order and Opening
Remarks Conflict of Interest Statement |
| 8:45 a.m. |
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Sponsor Presentation
(Purdue Pharma, L.P.) Introductory Comments Palladone Risk Management Plans Concluding Remarks |
| 9:45 a.m. |
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Questions from the
Committee |
| 10:00 a.m. |
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Abuse Liability |
| 10:30 a.m. |
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Break |
| 10:34 a.m. |
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Long Acting Opiates:
Challenges and Risks |
| 11:15 a.m. |
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FDA Presentation |
| 12:15 p.m. |
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Open Pubic Hearing |
| 12:45 p.m. |
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Lunch |
| 1:45 p.m. |
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Committee Discussion |
| 3:00 p.m. |
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Break |
| 5:00 p.m. |
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Adjournment |
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Chat Status: |
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