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.
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Legally, FDA can't require comparative effectiveness data for approval, but draft guidance notes that the agency really wants it; for sponsors, that leaves more questions than answers, mainly: What will FDA do with an opioid application that doesn't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Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety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.