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.
You may also be interested in...
New Opioids: Industry Stakeholders Support US FDA's Desire For Active Comparator Data
Although only a few companies commented on the FDA's draft guidance on the benefit/risk assessment of new opioids, they cut against conventional wisdom by supporting the agency's desire to see active comparator data.
Comparative Confusion: What Does FDA Intend For Opioid Comparative Efficacy 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Legally, FDA can't require comparative effectiveness data for approval, but draft guidance notes that the agency really wants it; for sponsors, that leaves more questions than answers, mainly: What will FDA do with an opioid application that doesn't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.
New Opioids May Need Comparative Effectiveness Data For Approval
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety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.