FDA Fee Waivers, Refunds and Reductions: Apply within 4-6 months of Need
​​​[Posted on: Thursday, June 21, 2018]

FDA charges fees for most market approval applications but grants waivers to a lot of applicants based on various criteria. A new Guidance document released this week, discusses all the various ways the fees can be reduced or waived by the FDA. In case the applicant has already paid the fee, the fee can be refunded provided the applicant requests the refund along with providing evidence of the eligibility for the refund within 180 days. Most fee waivers and reductions are based on either the financial condition of the applicant, the indication for which a given drug is being developed, and the size of the applicant. Although there is no new condition in this Guidance Document, it is an excellent primer for all new applicants for market approvals of new drugs and biologics. Some interesting points about the application process also are evident. For example, FDA strongly advises to not submit a fee waiver request more than 4 months before the application is expected to be filed. Also, in case the letter granting the waiver is not received by the time the applicant files the NDA or BLA, the applicant is better served by delaying the application till the grant letter is received or submit the fee and later request refund within 180 days of paying the fee one the fee waiver grant letter is received. The process to apply, logistics of how FDA decides to grant waivers, and timing of various applications is reviewed. Several interesting and important information is spread throughout the Guidance that should be a valuable read for most new market approval applicants to the FDA.