On June 20, 2018, FDA released guidance providing recommendations for requests for waivers, refunds, and reductions of user fees for drugs and biologics. The new guidance revises the 2011 guidance User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.
These user fees are assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revised draft guidance describes the procedures for requesting waivers, refunds, or reductions of these fees. It also describes the process to follow if FDA denies a company’s request. Clarification on related issues such as user fee exemptions for orphan drugs is also provided.
