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Lack Of Priority? No ANDAs Approved Using Expedited Pathway In FY 2018

 
• By Derrick Gingery

US FDA also refused to receive many priority generic drug applications, suggesting the expedited pathway may not be working as intended quite yet.

3d different tablets and pills on a white background with question marks

The US FDA did not approve any priority assessment ANDAs in fiscal year 2018, but did push a few applications through another expedited pathway, signaling that industry may not fully understand the new system intended to help speed generic drugs to market.

Priority assessments were introduced in 2017 as part of the FDA Reauthorization Act. Under the pathway, sponsors can receive an...

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More from Biosimilars & Generics

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

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