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Q&A Guidance Doc Dives Into Combination Product User Fees

 
• By Elizabeth Orr

The document explains how user fees for combination products are assessed and administered, as well as waiver possibilities.

Transfer of money from hand to hand.
• Source: Shutterstock

Newly finalized guidance from the US Food and Drug Administration lays out how the agency assesses user fees for combination products, as well as how sponsors can qualify for waivers and other programs that may reduce cost.

“Application User Fees for Combination Products Guidance for Industry and FDA Staff,” which replaces a 2005 guidance document of...

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