US FDA Begins Implementing New User Fee Programs, But What About The Actual Fees?
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.
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The revenue is expected to sustain the prescription drug user fee program moving forward after reserves were tapped at the start of fiscal year 2023.
Carryover funds are limited after agency's collections schedule was altered by late user fee program renewal in Congress.
Carryover funds are limited after the agency's collections schedule was altered by the late user fee program renewal.