FDA's Califf on accelerated approval: 'In God, we trust, everyone else must bring good evidence'

When FDA Commissioner Robert Califf, M.D., says the agency’s accelerated approval program is personal, he’s not being cliche. Califf’s mother was able to access multiple myeloma treatment because of it, extending her life.

But now, seven weeks into the job, Califf is not naive about the debate surrounding the program, which has become his first big test. In an exclusive interview with Fierce Biotech, Califf said the first order of business for reviving trust in the program is improving the necessary confirmatory trials.