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Drug developers see Food and Drug Administration 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.


That’s our assessment as individuals who have guided drug development and modeling clinical trials and as a former reviewer (J.B.) with the FDA.

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