In the September 28, 2015, Federal Register, FDA announced the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2016 ($2,727,000). The amount of the fee for using a rare pediatric disease priority review voucher is determined each year based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous year.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.