UNITED STATES – FDA is announcing a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to be held on April 19.
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. Anyone interested may present data, information, or views (orally or in writing) on these committee issues.
FDA intends to publish a Federal Register notice and establish a docket for public comment on this meeting by March 2023. Those interested in making formal oral presentations during the open public hearing session of the meeting should follow the instructions in the Federal Register Notice when it publishes.
The agency will provide a free webcast of this meeting and plans to post the archived webcast after the meeting barring technical problems.
Please visit the advisory committee meeting webpage for more information and any updates.
