FDA Medical Countermeasures Initiative (MCMi) reports and annual program updates

• 
  MCMi Fiscal Year 2020 Program Update - about this report - download a printable PDF (PDF, 4.3 MB)
• MCMi Fiscal Year 2019 Program Update (PDF, 1.3 MB)
• MCMi Fiscal Year 2018 Program Update (PDF, 4 MB)
• MCMi Fiscal Year 2017 Program Update (PDF, 2.6 MB)
• MCMi Fiscal Year 2016 Program Update (PDF, 1.6 MB)
• MCMi Fiscal Year 2015 Program Update (PDF, 2.7 MB)
• MCM-related legal and policy presentations, publications and Q&As
• MCM regulatory science presentations

Other FDA publications

• FDA Office of the Chief Scientist reports:
  • Focus Areas of Regulatory Science - The 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Public health preparedness and response is a focus area, including medical countermeasures and preparedness for emerging infectious diseases. Please contact FARS@fda.hhs.gov with questions about this initiative. (January 2021)
  • Advancing Alternative Methods at FDA - Read about the activities FDA scientists are undertaking to spur the development of new regulatory approaches that can help improve predictivity--and potentially replace, reduce and/or refine animal testing. (January 2021)
  • FDA's Predictive Toxicology Roadmap - Published in December 2017 by the FDA's Toxicology Working Group, this roadmap describes FDA’s thoughts on viable ways to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate them into FDA regulatory review.
• See our Antimicrobial Resistance Information from FDA page for FDA publications related to AMR
• See our Advanced Manufacturing page for FDA publications related to advanced manufacturing

Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), Assistant Secretary for Preparedness and Response (ASPR), and other federal reports

• Executive Order 14017 on America’s Supply Chains: HHS recommendations to help shore up the U.S. pharmaceutical supply chain - Keeping the U.S. drug supply chain secure, robust, and resilient is essential for the health and national security, and economic prosperity of the United States during emergencies like the COVID-19 pandemic and for the provision of day-to-day health care. On February 24, 2021, President Biden signed Executive Order 14017 to secure America’s critical supply chains. The Executive Order directed the Administration to launch an immediate 100-day review and strategy development process to identify and address vulnerabilities in the supply chains of four key product sectors, including pharmaceuticals. HHS led the development of a pharmaceutical supply chain report and its recommendations, which were published in a White House report (PDF, 6.1 MB) on June 8, 2021. 
• National Biodefense Strategy information from HHS
• PHEMCE Multiyear Budget FY 2017 – 2021 (PDF, 2.1 MB), published by HHS ASPR, May 2019 - FDA-specific information begins on page 31.
• 2019-2022 National Health Security Strategy (NHSS), published by HHS ASPR, January 2019
• U.S. Health Security National Action Plan: Strengthening Implementation of the International Health Regulations (PDF, 2.1 MB), published by HHS/ASPR, and based on the 2016 Joint External Evaluation, October 2018 - more about this plan
• Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan, published by HHS ASPR
• HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework - PDF, 718 KB), December 2017 - also see NIH Lifts Funding Pause on Gain-of-Function Research
• Project BioShield Annual Reports to Congress, published by HHS ASPR
• PHEMCE Enterprise Review materials, HHS ASPR, 2010

Related Links

• MCMi in Action: Protecting National Health and Security
• MCM-Related Counterterrorism Legislation