Snapshot

The FDA Priority Review pathway has been developed by the US Food and Drug Administration of United States.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). FDA informs the applicant of a Priority Review designation within 60 days of the receipt of the original BLA, NDA, or efficacy supplement.