Opioid Public Meeting Will Focus On Approval Standards, Development Incentives

The US FDA has plenty of questions about potentially requiring new opioid analgesics to show they provide an advantage over approved products. How would the advantage be quantified? Which existing products would be the comparators? Should there be any exceptions?

These are among the questions the agency posed in a Federal Register notice announcing a 17 September public hearing on "Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction