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EIN Presswire: FDA recommends changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder
We also received similar feedback through several meetings in which FDA participated, including a two-day public meeting with the Reagan-Udall Foundation for the FDA in May 2023 and two listening sessions led by the Substance Abuse and Mental Health Services Administration (SAMHSA) in November and December 2023.
Federal Register: Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence
In May 2023, the Reagan-Udall Foundation hosted a 2-day public meeting with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA), entitled “Considerations for Buprenorphine Initiation and Maintenance Care.”