FDA plays a pivotal role in protecting our nation from chemical, biological, radiological, and nuclear threats, and from emerging infectious diseases. FDA’s responsibility is to ensure that medical countermeasures (MCMs)—such as drugs, vaccines, and diagnostic tests—to counter these threats are safe, effective, and secure. Working closely with its partners through the U.S. Department of Health and Human Services’ Public Health Emergency Medical Countermeasures Enterprise, FDA develops and sustains the MCM programs necessary to respond to a public health emergency.
In August 2010, FDA launched the Medical Countermeasures initiative (MCMi) to build on existing FDA MCM programs and strengthen FDA activities by enhancing the regulatory review process for the highest priority MCMs and related technologies; advancing regulatory science for MCM development; and modernizing our regulatory and legal framework.
A comprehensive overview of MCM activities underway across the agency can be found on FDA's MCMi Web page.