The fiscal year 2023 US government funding bill moving through Congress this week includes accelerated approval pathway reforms aimed at giving the Food and Drug Administration more authority to ensure the timely enrollment and completion of confirmatory trials.
However, the agency would appear to have considerable discretion in deciding when to require that a confirmatory study
In addition, provisions aimed at speeding the process for withdrawing accelerated approval drugs appear to reduce, but do not entirely eliminate, the cumbersome bureaucratic process for getting a