Coming Soon: New US FDA Opioid Plan
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.
You may also be interested in...
Opioid Diversion, Postal Carrier Dangers Among Industry Concerns With Mail-Back Envelope Requirement
Brand and generic drug sponsors also tell the US FDA that there are environmental considerations for providing a pre-paid mail-back envelope so patients can send unused opioids for disposal.
The move should increase the visibility of the FDA’s wide-ranging, and widely criticized, opioid epidemic response.
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.