Posted by Michael Wonder on 31 Jan 2023
FDA may not always require post-approval trials to be enrolled before accelerated approvals
30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority to make drug companies enrol post-market clinical trials before granting speedy drug approvals.
That new power is part of reforms to the FDA's accelerated approval path that Congress recently passed.
