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Dsuvia Gets Warning Letter As US FDA’s Opioid Decisions Complicate Commissioner Race

 
• By Sarah Karlin-Smith

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.

The Dsuvia warning letter drew a lot of attention from FDA officials.

The US Food and Drug Administration warned opioid maker AcelRx Pharmaceuticals, Inc. for false and misleading promotion of Dsuvia on 11 February, just a few weeks after the agency’s acting Commissioner Janet Woodcock became the target of public criticism for her role in FDA decisions that are perceived as contributing to the country’s opioid epidemic.

While there is no indication the AcelRx warning letter, which was publicly announced 16 February, was deliberately sent now...

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US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice

 
• By Kate Rawson

Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
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