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Tag: Biologics license application

Explore our medication guides and pharmacology articles within this category.

How long does it take to get a fast track designation?

3 min read
In 2021, 36% of new drugs were designated as Fast Track by the FDA [1.2.4]. But **how long does it take to get a fast track designation**? The FDA is required by statute to make a decision within 60 days of receiving the request [1.2.1, 1.4.2].