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.

Read Stat News article

Michael Wonder

Posted by:

Michael Wonder