PhRMA Comments on FDA Enhanced Review Program

Pharmaceutical Research and Manufacturers of America (PhRMA) says it supported establishment of the FDA Program for Enhanced Review Transparency and Communication under PDUFA 5 and looks forward to working with the agency on it during PDUFA 6. “The PFUDA 6 proposed commitment letter builds upon the success of the program since implementation in 2012 and maintains the program’s high standards for quality, safety, and efficacy, and FDA’s global leadership position on timely regulatory review,” it says in a comment on the agency’s final program assessment. “To date, the program has proven to be effective in increasing the likelihood of first-cycle approval for NME NDAs and original BLAs.”

The association offers specific comments on the final report dealing with program resources, PDUFA goal extensions and major amendments, inspections, and review communications.