Opioid Public Meeting Will Focus On Approval Standards, Development Incentives

US FDA also seeking feedback on whether the agency needs new authorities to better regulate opioid products.

Microphone over the Abstract blurred photo of conference hall or seminar room with attendee background - Image

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...

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