Posted by Michael Wonder on 05 Jun 2022
The FDA’s Pazdur on accelerated approval, single-arm studies and his own future
4 June 2022 - When cancer drugs granted accelerated approval in the U.S. later turn out not to benefit patients, the FDA would prefer drug makers remove them from the market voluntarily.
But very few companies are willing to do that, which sometimes forces Richard Pazdur, the agency’s top cancer drug regulator, to pick up the phone and have a blunt conversation with drug company executives.
