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.
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Although only a few companies commented on the FDA's draft guidance on the benefit/risk assessment of new opioids, they cut against conventional wisdom by supporting the agency's desire to see active comparator data.
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.