  November 28, 2022, 2:30pm - 3:30pm ET
Please join us for a stakeholder call to discuss naloxone access. Speakers will include FDA Commissioner Dr. Robert Califf and Marta Sokolowska, Deputy Center Director for Substance Use and Behavioral Health in FDA's Center for Drug Evaluation and Research. Dr. Miriam Delphin-Rittmon, SAMHSA Assistant Secretary for Mental Health and Substance Use, will also participate on the call.
Join Zoom Meeting
Meeting URL:https://fda.zoomgov.com/j/1609129068?pwd=aFQxV3hFUWlIUk1sMmh5MXVyeE0rZz09
Passcode: J7y%Sn
Phone: Dial(for higher quality, dial a number based on your current location):
US: +1 669 254 5252 or +1 646 828 7666 or +1 551 285 1373 or +1 669 216 1590
Webinar ID: 160 912 9068
Passcode: 833323
Background
Every person who experiences an opioid overdose, whether it is with prescribed medication or an illicit drug, should have access to naloxone. Entities such as harm reduction programs help save lives by making naloxone available in underserved communities. The agency intends to stand by these efforts by supporting their ability to acquire FDA-approved naloxone products, and we recently issued the guidance, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency. At the same time, the agency recognizes that this action alone is not enough, and there is still more work ahead.
About Us
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.
Contact the Stakeholder Engagement Staff at: FDAStakeholderEngagementTeam@fda.hhs.gov
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