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# MCM Annual Report Achievements
- URL: https://www.fdaweb.com/mcm-annual-report-achievements/
- Published: 2023-02-15T12:00:00.000Z
- Updated: 2026-09-14T18:16:08.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5153784

The FDA *MCMi Program Update* annual report describes the agency’s efforts to ensure that medical countermeasures (MCMs), such as drugs, vaccines, and diagnostic tests, are safe, effective, and secure as they protect the U.S. from chemical, biological, radiological, nuclear (CBRN), and emerging infectious disease threats. The [report](https://www.fda.gov/emergency-preparedness-and-response/about-mcmi/mcmi-program-update?utm%5Fmedium=email&utm%5Fsource=govdelivery) says that in addition to its regulatory responsibilities, FDA works closely with U.S. government partners to build and sustain the MCM programs necessary to effectively respond to public health emergencies.

Key agency activities to facilitate the development of and access to MCMs are:

- supporting developers, manufacturers, researchers, and others in developing new and innovative MCMs to meet FDA’s standards;
- providing regulatory advice, guidance, and technical assistance to sponsors developing investigational MCMs for CBRN or emerging infectious disease threat indications;
- discussing questions with potential product sponsors to help clarify requirements for approval or emergency use authorization;
- reviewing MCM marketing applications and approving those meeting approval standards;
- supporting the establishment and sustainment of an adequate supply of MCMs;
- enabling access to available MCMs that are not yet approved for use when necessary;
- responding to emerging and re-emerging public health threats;
- establishing and sustaining Public Health and Security Action Teams to identify and catalyze the resolution of regulatory and scientific challenges associated with MCMs to address high-priority threats;
- developing capabilities to monitor and assess MCMs used during public health emergencies;
- collaborating with U.S. government partners developing MCMs;
- sustaining the MCM regulatory science program to create tools, standards, and approaches to develop and assess MCM safety, efficacy, quality, and performance;
- encouraging manufacturers to develop innovative and emerging approaches to produce medicines through advanced manufacturing techniques;
- ensuring that the FDA legal, regulatory, and policy framework adequately supports MCM development and enables preparedness and response activities; and
- sustaining the MCM professional development program to ensure that FDA personnel maintain the requisite skills and abilities to support the MCM mission.