Comparative Confusion: What Does FDA Intend For Opioid Comparative Efficacy Data?
Executive Summary
Legally, FDA can't require comparative effectiveness data for approval, but draft guidance notes that the agency really wants it; for sponsors, that leaves more questions than answers, mainly: What will FDA do with an opioid application that doesn't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.
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Although only a few companies commented on the FDA's draft guidance on the benefit/risk assessment of new opioids, they cut against conventional wisdom by supporting the agency's desire to see active comparator data.
Dsuvia: A Dull US FDA Review Preceded The Controversial Approval
US FDA's review of AcelRx's opioid Dsuvia did not presage the external fireworks that came following the approval.
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.