US FDA Looking For Senior Leader In New Drugs Office To Oversee Substance Use Disorder Issues
The deputy Office of New Drugs director will have decision-making authority and help shape policy for substance use efforts.
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New Opioid Labeling Further Constrains Use, Urges Prescribing Only By Docs ‘Knowledgeable’ About Risks
US FDA’s mandated labeling changes come after the agency required manufacturers to provide mail-back envelopes for opioid disposal.
Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.
Unlike prior plans, the FDA’s new substance abuse framework is intended to deal with stimulant and benzodiazepine use disorders, in addition to opioid abuse.