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Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee
June 11, 2019 - June 12, 2019
The FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient setting. The FDA is interested in better understanding current clinical use and situations that may warrant use of higher doses of opioid analgesics. The FDA is also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients.