FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programs

The U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter products.

The agency said the fees are calculated by matching its resource needs with the number of applications it expects to receive. Historical filing trends were used to estimate future workload.

Industry participants will use the new rates to plan budgeting and pricing strategies for upcoming submissions.

The announcement provides transparency on the cost structure that companies will face when seeking regulatory approval in the coming year.