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An Update on FDA's Overdose Prevention Framework - Addressing Critical Areas of Need

An update on activities FDA is taking across the agency in each of the Overdose Prevention Framework priorities. ....

United States , Robertm Califf , White House Office Of National Drug Control , National Academies Of Science , Clinical Laboratory Improvement , International Overdose Awareness Day , National Response Plan , Udall Foundation , Digital Health Center , Drug Administration , Emergency Medical Service , Drug Enforcement Administration , American Dental Association , University Of Pittsburgh , Medasense Biometrics Ltd , Prevention Framework , Overdose Prevention Framework , June National Academies , Drug Supply Chain Security Act , March Reagan Udall Foundation , Clinical Laboratory Improvement Amendments Waived , Masimo Safetynet Opioid System , Opioid Induced Respiratory Depression , Medasense Biometrics , Nociception Level , Devices Intended ,

FDA approves second over-the-counter naloxone nasal spray for opioid overdose

FDA approves second over-the-counter naloxone nasal spray for opioid overdose
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Robert Califf , Drug Administration , Harm Reduction Therapeutics , Overdose Prevention Framework ,

FDA Takes Steps to Facilitate Innovation for Devices Intended to Treat Opioid Use Disorder

The draft guidance, to help sponsors design clinical studies to evaluate these devices, furthers the FDA’s Overdose Prevention Framework goal of advancing evidence-based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. ....

Jeff Shuren , Robertm Califf , Radiological Health , Drug Administration , Us Department Of Health , Human Services , For Immediate Release , Prevention Framework , Clinical Considerations , Devices Intended , Treat Opioid Use Disorder , Overdose Prevention Framework ,

FDA Roundup: June 23, 2023

/PRNewswire/ Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued an. ....

Oncology Center , Drug Development , Drug Administration , Office Of Media Affairs , Consumer Update , Overdose Prevention Framework , Excellence Patient Focused Drug Development , Clinical Outcome Assessment , Cancer Clinical Trials , Media Affairs ,

FDA Approves Buprenorphine for Opioid Use Disorder

Buprenorphine is available either in a weekly injection formulation and a monthly formulation for patients already being treated with buprenorphine. ....

Robertm Califf , Drug Administration , Overdose Prevention Framework ,