FDA has established Public Health and Security Action Teams (Action Teams) to enhance the product review process for medical countermeasures (MCMs). These teams of subject matter experts review MCM development pipelines and help identify potential gaps in regulatory, scientific, or policy areas that may delay MCM approvals.
The Action Teams work with internal and external experts to identify challenges to navigating the MCM development pathway. Action Teams foster MCM development by facilitating the use of consistent regulatory approaches, and helping identify and implement best regulatory review practices across FDA medical product centers.
The Medical Countermeasures Initiative (MCMi) has helped increase the number of scientists involved in the review of MCM-related medical product applications FDA-wide, and continually promotes understanding of MCM-related issues through events and professional development.