Patient Groups Fume Over Lack of Voice in MDUFA Negotiations

Patient advocacy groups used a March 28 FDA public forum on reauthorization of device user fees to lambast the FDA for sidelining them in recent Medical Device User Fee Act (MDUFA) negotiations. “It’s clear this agreement does not reflect our comments or priorities,” said Kate Ryan, a program coordinator at the National Women’s Health Network (NWHN).
Devices & Diagnostics Letter