Dsuvia Approval May Be Followed By New Opioid Review Paradigm At FDA
US FDA Commissioner Gottlieb defended the decision to clear the controversial opioid in the agency’s press release on the approval, and announced a possible shift in how future opioid applications are reviewed.
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Nektar's Novel Opioid For Lower Back Pain Heads To US FDA Panel For Wide-Ranging Discussion
Nektar's novel opioid oxycodegol will be the first opioid analgesic taken up by an advisory committee in more than a year after the agency spent 2019 reevaluating its regulatory paradigm.
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Legally, FDA can't require comparative effectiveness data for approval, but draft guidance notes that the agency really wants it; for sponsors, that leaves more questions than answers, mainly: What will FDA do with an opioid application that doesn't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.
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.