US FDA Works To Stay Ahead Of Benzodiazepine Misuse
FDA and NIH are looking to spark research on approaches to reduce use of benzodiazepines and to help mitigate issues with withdrawal associated with the widely prescribed therapies.
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US FDA Elevates Controlled Substances Coordinator To New Deputy CDER Director Role
The move should increase the visibility of the FDA’s wide-ranging, and widely criticized, opioid epidemic response.
Opioid Labeling Instructions On Naloxone Are Compromise In Co-Prescribing Debate
US FDA says opioid and opioid use disorder treatment labels should suggest providers discuss naloxone availability with patients and caregivers and consider co-prescribing to patients at high-risk of overdose, but it does not mandate co-prescribing, the most aggressive (and costly) option that had been considered.
Opioid 'Data Warehouse' Is Part Of US FDA's New Controlled Substances Program
CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.