How long does it typically take for the FDA to review a NDA?

The FDA's review time for a New Drug Application (NDA) typically varies based on several factors, including whether the application is designated for priority review or standard review.

• Priority Review: For drugs that offer significant therapeutic improvements, the FDA aims to complete the review within 6 months under the Prescription Drug User Fee Act (PDUFA) goals134.

• Standard Review: For drugs that do not meet the criteria for priority review, the FDA typically aims to complete the review within 10 months134.

The review process begins after the FDA accepts the NDA for filing, which is usually determined within 60 days of submission245. If a major amendment is submitted during the review, the timeline can be extended by up to 3 months1. Overall, the entire process, from submission to approval, typically takes about 1 year3.