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This announcement may be considered further progress in the implementation of the FDA Overdose Prevention Framework designed to prevent overdoses and reduce mortality.
The Food and Drug Administration (FDA) has issued draft guidance to facilitate the development of treatments for substance use disorders related to stimulants like cocaine and methamphetamine. The FDA’s draft guidance lays out the agency’s recommendations on the development of clinical trials for drugs aimed at treating moderate to severe cocaine use disorder, methamphetamine use…
/PRNewswire/ -- Today, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use...
An update on activities FDA is taking across the agency in each of the Overdose Prevention Framework priorities.
The draft guidance, to help sponsors design clinical studies to evaluate these devices, furthers the FDA’s Overdose Prevention Framework goal of advancing evidence-based treatment for those with substance use disorders.