The U.S. Food and Drug Administration's Stakeholder Engagement Staff invites you to an important stakeholder call on expanding access to Naloxone on Thursday, March 30, 2023, at 11:00 am ET.
Speakers will include Stephen Cha, M.D., Counselor to Secretary at U.S. Department of Health and Human Services, Robert M. Califf, M.D., Commissioner of Food and Drugs, and Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health in FDA's Center for Drug Evaluation and Research.
https://fda.zoomgov.com/j/1616393315?pwd=SFc3QzA2MGEzWW1OMnZOUDdSNEZqZz09
Meeting ID: 161 639 3315
Passcode: A=gj0b
FDA Approves First Over-the-Counter Naloxone Nasal Spray
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.
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.
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