Three steps can help companies speed FDA approval of new drugs

Stat News

24 February 2021 - Drug developers see FDA approval as a difficult uphill climb, requiring large investments of resources and time. 

But when it comes to new drug applications and biologics license applications, it’s usually not the FDA that slows down the process.

The main reason for delays and extensions is that sponsors submit their applications too soon.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Timelines