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Comparative Confusion: What Does FDA Intend For Opioid Comparative Efficacy Data?

 
• By Derrick Gingery

Legally, FDA can't require comparative effectiveness data for approval, but draft guidance notes that the agency really wants it; for sponsors, that leaves more questions than answers, mainly: What will FDA do with an opioid application that doesn't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.

Drugs question mark
How will FDA react if an opioid application does not include comparative efficacy and safety data? • Source: Shutterstock

The US Food and Drug Administration's interest in using comparative effectiveness information in its assessments of new opioid applications may confuse sponsors about the data's role and whether it is unofficially required for approval.

Grievances and questions about the legality of considering superiority data and the agency's interpretation of comparative advantage likely will highlight the written comments as well as the upcoming public meeting...

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UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
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