U.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of the Chief Scientist, and Office of Counterterrorism and Emerging Threats. (2018). Material Threat Medical Countermeasure Priority Review Vouchers Guidance for Industry.
This draft guidance document includes information regarding the implementation of section 3086 of the 21st Century Cures Act (Cures Act) (Public Law 114-255), which added section 565A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-4a). Section 565A requires the Food and Drug Administration “to award a priority review voucher (PRV) to sponsors of certain medical countermeasure (MCM) applications that meet the criteria specified in that section.”