The committee will discuss postmarketing requirement (PMR) 3033-11, issued to application holders of new drug applications (NDAs) for extended-release and long-acting (ER/LA) opioid analgesics to evaluate long-term efficacy of opioid analgesics and the risk of opioid-induced hyperalgesia. The discussion will focus on a clinical trial designed to address these objectives.
Link to Meeting Information and Materials: https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-19-2023-meeting-anesthetic-and-analgesic-drug-products-advisory-committee-meeting-announcement
Link to Meeting Information and Materials: https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-19-2023-meeting-anesthetic-and-analgesic-drug-products-advisory-committee-meeting-announcement
- Category
- Management

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