The future of the prescription drug user fee program is uncertain, impacting regulatory operations.
User fees play a critical role in supporting FDA operations, especially in drug evaluations.
Feedback collection by the FDA aims to shape the next version of the Prescription Drug User Fee Act.
Regulatory operations depend heavily on user fees, indicating a need for program reform.
Abstract
The FDA has begun soliciting feedback to inform the next version of the Prescription Drug User Fee Act. User fees remain critical for supporting regulatory operations, but the program's future is unclear.