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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AcelRx oversimplified Dsuvia’s ease of use, Office of Prescription Drug Promotion says. Focus on opioid safety comes as critics of Janet Woodcock have pointed to FDA’s decisions in the space as disqualifying her for FDA commissioner. Letter appears to reflect long-standing FDA concerns: Dsuvia was approved with a REMS related to administration issues, and Xeris received a similar warning letter last year for exaggerating the ease of use of its glucagon pre-filled syringe Gvoke PFS.
Opioid issues delayed Robert Califf’s confirmation as FDA commissioner. Could they prevent the nomination of Janet Woodcock?
Several firms reporting quarterly earnings this week discussed how the outbreak is affecting supply chains, drug launches and clinical trials.