The US FDA has posted details, including company and FDA Briefing Materials, for the Wednesday, October 5, 2016, joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee. The Committees will discuss the most appropriate dose or doses of naloxone products to reverse the effects of life-threatening opioid overdose in all ages, and the role of having multiple doses available in this setting. The Committees will also discuss the criteria that prescribers will use to select the most appropriate dose in advance of an opioid overdose event and the labeling to inform this decision, if multiple doses are available.
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