Material Threat Medical Countermeasure Priority Review Vouchers; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Material Threat Medical Countermeasure Priority Review Vouchers." There is stakeholder interest in FDA's implementation of the provision of the 21st Century Cures Act (Cures Act) that adds a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act) on priority review vouchers for material threat medical countermeasure applications. This new section of the FD&C Act makes provisions for awarding priority review vouchers for use with applications to sponsors of material threat medical countermeasure applications that meet the criteria specified by the FD&C Act. This draft guidance explains to internal and external stakeholders how FDA intends to implement the provisions of the new section of the FD&C Act.