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.
You may also be interested in...
FDA Reforms Missed By FDORA Could Find Vehicle In Animal Drug User Fee, Pandemic Bills
The usually lower-profile user fee reauthorizations could gain more attention for broader US FDA issues, said Andi Lipstein Fristedt, FDA deputy commissioner for policy, legislation and international affairs.
Unannounced Foreign Drug Inspection Pilot, Other US Inspection Measures Enacted
A suite of pharmaceutical inspection measures stripped from the user fee renewal legislation were added to the US FY 2023 spending law, including provisions for new inspection priorities, remote alternatives, mutual reliance, internal FDA coordination and unannounced foreign inspections.
Pink Sheet’s Top Seven Infographics Of 2022
From US drug pricing to Japan’s Sakigake expedited pathway, important regulatory developments and trends are easier to understand and track with Pink Sheet graphics.