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Opioid Abuse-Deterrent Formulations Could Become Prerequisite To Approval

 
• By Cathy Dombrowski

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recommends against approval of Zogenix’s Zohydro ER as it seeks safer formulations and stricter REMS for all extended-release/long-acting opioids.

FDA is examining the feasibility of requiring abuse-deterrence as a criterion for approving opioids or other abusable drugs.

“As we gain experience with both laboratory and real-world data concerning new opioid products formulated to deter abuse, we are...

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Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 
• By Sarah Karlin-Smith

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.