Commenters have recently argued that the US FDA’s drug approval standards are becoming inappropriately low and that the required post approval evaluations are either inadequate or left undone. But three senior FDA officials offered several counterpoints this week at the fifth annual Biopharma Congress in Washington, DC. Janet Woodcock, director of the FDA’s CDER explained that the agency is working on its own analyses to provide “a more robust response” to these critiques. She also explained how the high number of approvals in recent years for rare diseases may be influencing this perception of a lower bar, especially as more treatments are approved. Learn More