Dsuvia Gets Warning Letter As US FDA’s Opioid Decisions Complicate Commissioner Race
Executive Summary
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.
You may also be interested in...
Califf Likely To Find Many Familiar Problems Upon Return To US FDA Helm
President Biden’s pick for FDA commissioner should remember many of the hot-button issues that he would face upon confirmation, such as drug pricing and approval standards.
Robert Califf Likely To Find Many Familiar Problems Upon His Return To US FDA
President Biden’s pick for FDA commissioner should remember many of the hot-button issues that he would face upon confirmation, such as drug pricing and approval standards.
Responding To Rx Drug Promo Violations: Tips From OPDP
US FDA's staff have sometimes worked late into the night to help sponsors meet deadlines and avoid errors in responding to a notice of violation. As is often the case, early communication helps avoid problems.