USA – FDA Finalizes Guidance on PDUFA Fee Waivers, Reductions and Refunds

The US Food and Drug Administration (FDA) on Wednesday finalized guidance providing advice to drug and biologic sponsors looking to apply for Prescription Drug User Fee Act (PDUFA) fee waivers, reductions and refunds.

Specifically, the guidance explains the various types of fee waivers, reductions and refunds offered to industry, such as those for pressing public health needs, small business entities and when paying the fee would be a significant barrier to an applicant’s ability to develop a drug.

The 29-page guidance finalizes a draft version released for comment in June 2018, which in turn was an update to the agency’s previous final guidance on the topic from 2011.
 
The guidance is nearly identical to the draft version with only a few minor additions and editorial changes…