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Although only a few companies commented on the FDA's draft guidance on the benefit/risk assessment of new opioids, they cut against conventional wisdom by supporting the agency's desire to see active comparator data.
Legally, FDA can't require comparative effectiveness data for approval, but draft guidance notes that the agency really wants it; for sponsors, that leaves more questions than answers, mainly: What will FDA do with an opioid application that doesn't contain such 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Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety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.