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.”