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New FDA Guidance on PDUFA Fee Waiver, Reductions, and Exemptions Issues

It has been a while since the FDA updated its guidance on PDUFA fee waivers, etc., but the newly released Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products document provides much needed new information about the FDA’s fee program.  The Federal Register Notice (here) announcing the availability of the guidance states:

“This guidance describes the types of waivers, reductions, and refunds permitted under the user fee provisions of the FD&C Act and the procedures for submitting requests for waivers, reductions, refunds, as well as requests for reconsiderations or appeals.  The guidance also provides additional clarification on certain issues such as user fee exemptions for orphan drugs and FDA’s current thinking on considerations relevant to eligibility for user fee waivers, reductions, and refunds under the applicable statutory provisions.”

The guidance document also discusses how the program fee waivers will be handled and the basic FDA assumptions for meeting financial requirements to be eligible for waivers or reductions.  The full guidance can be found here.