1. Pink Sheet

Predicting The User Fee Reauthorization Schedule

 
• By Derrick Gingery and Nielsen Hobbs

PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be followed by BsUFA talks.

User Fee Reauthorization Preview 2020
Industry and US FDA officials likely will meet for months to hammer out the agreements needed to reauthorize the three user fee programs. • Source: Pink Sheet illustration

The US Food and Drug Administration hasn't announced the initial public meetings to discuss the structure of the next iterations of the user fee programs, but a look at the last two cycles suggests that they could be scheduled for late spring or mid-summer.

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