FDA Outlines Its Medical Countermeasures Priority Review Voucher Program

FDA has clarified through guidance the details of its newest voucher program, which was established through the 21st Century Cures Act and is intended to incentivize sponsors of material threat medical countermeasure (MCM) products -- those that diagnose, prevent or treat illness caused by chemical, biological, radiological and nuclear threats and emerging infectious diseases -- by expediting their review. The guidance was released Wednesday (Jan. 17), the same day FDA Commissioner Scott Gottlieb signaled to lawmakers that a voucher may...