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A 3-Month Delay For A Better Label: US FDA User Fee Goal Extensions Are Usually Good News

 
• By Bridget Silverman

Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.

review extension celebration
Should sponsors be celebrating user fee extensions as a sign of review progress? • Source: Nieslen Hobbs; the Pink Sheet | Shutterstock images

Major amendments containing new clinical trial data or analyses are driving the high usage of three-month extensions to PDUFA goal dates over the past year, an analysis of the Pink Sheet’s US FDA Performance Tracker shows.

Furthermore, those major amendments are followed, overwhelmingly, by FDA approval.

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