To reduce morbidity and mortality associated with overdoses, FDA is:
Expanding availability and access to overdose reversal products, including naloxone, by supporting accelerated review of products and exploring over-the-counter access.
Supporting development of novel overdose reversal products.
Supporting development and authorization of fentanyl test strips to test human specimens at the point of care.
United States Government Partners
Department of Health & Human Services (HHS)
National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)
Centers for Medicare & Medicaid Services (CMS)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Indian Health Service (IHS)
FDA Activities
Naloxone
FDA Opioid Systems Modeling Effort
Abuse-Deterrent Formulations
Disposal of Unused Medicines: What You Should Know
Safety Measures for Extended-release and Long-acting (ER/LA) Opioids
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
Safety Measures for Immediate Release (IR) Opioids
Oxymorphone (marketed as Opana ER) Information
SUPPORT Act Section 6012: Report on Abuse-Deterrent Opioid Formulations and Access Barriers Under Medicare
Safety Measures for Opioid Analgesics, Prescription Opioid Cough Products, and Benzodiazepines
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