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.
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The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.
Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.