1. Pink Sheet

Drug Review Times Are Not Shortened Much By Single Expedited Review Designation

 
• By Derrick Gingery

Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.

FDA approved background, 3D rendering, blue street sign
Applications qualifying for multiple expedited programs on average gained a more substantial reduction in assessment time, the GAO found. • Source: Shutterstock

Expedited programs usually shorten a US Food and Drug Administration new drug application assessment, but on average, maybe not as much as their reputation would suggest.

A Government Accountability Office (GAO) analysis found that expedited assessment programs generally are significant variables affecting assessment times, but...

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