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US FDA Begins Implementing New User Fee Programs, But What About The Actual Fees?

 
• By Derrick Gingery

Sponsors looking to file applications continue to wait for the new user fees to be announced, as details of the Split Real-Time Application Review (STAR) program, generic drug facility inspection readiness requirement and other changes are revealed.

waiting room
Sponsors continue to wait for the FDA to announce the FY 2023 user fees. • Source: Shutterstock

US Food and Drug Administration officials are releasing guidances and announcements describing new user fee-related activities now that the programs have been reauthorized by Congress.

However, likely the biggest user fee questions remain unanswered, including what the new fees will cost and what sponsors with applications ready for submission should do in the meantime.

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