Publications and Reports
FDA Medical Countermeasures Initiative (MCMi) reports and annual program updates
- MCMi Fiscal Year 2021 Program Update - about this report - download a printable PDF (PDF, 1.4 MB)
- MCMi Fiscal Year 2020 Program Update (PDF, 4.3 MB)
- MCM-related legal and policy presentations, publications and Q&As
- MCM regulatory science presentations
- MCMi Fiscal Year 2019 Program Update (PDF, 1.3 MB - ARCHIVED)
- MCMi Fiscal Year 2018 Program Update (PDF, 4 MB - ARCHIVED)
- MCMi Fiscal Year 2017 Program Update (PDF, 2.6 MB - ARCHIVED)
- MCMi Fiscal Year 2016 Program Update (PDF, 1.6 MB - ARCHIVED)
- MCMi Fiscal Year 2015 Program Update (PDF, 2.7 MB - ARCHIVED)
- MCMi Fiscal Year 2014 Program Update (PDF,1.3 MB - ARCHIVED)
- MCMi Fiscal Year 2013 Program Update (PDF, 1.3 MB - ARCHIVED)
- MCMi Year 2 Program Update (PDF, 291 KB - ARCHIVED), 2012
- MCMi Year 1 Status Report (PDF, 191 KB - ARCHIVED), 2011
Other FDA publications
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FDA's Work to Combat the COVID-19 Pandemic (PDF, 4.9 MB) - Outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies. (August 2022)
- FDA Office of the Chief Scientist reports:
- Focus Areas of Regulatory Science - Updated in 2022, this 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.
- 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
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In October 2022, HHS announced actions the department will take following National Security Memorandum 15, signed by President Biden, directing implementation of the 2022 National Biodefense Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (PDF, 547 KB). The strategy and implementation plan detail a coordinated approach to address the challenges from naturally occurring, deliberate, and accidental biological threats. These threats are among the most serious threats facing the U.S. and the international community. The 2022 strategy builds on the 2018 National Biodefense Strategy, incorporating lessons learned during the COVID-19 pandemic, and laying out a comprehensive implementation plan with bold, concrete actions to transform our health security.
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Essential Medicines Report Now Available - The nation’s first Essential Medicines Supply Chain and Manufacturing Resilience Assessment by the U.S. government was released by HHS/ASPR. The assessment addresses pharmaceutical supply chain constraints identified in the Biden-Harris Administration’s 100-day supply chain review report, specifically those constraints affecting critical medicines on FDA’s essential medicines list. Download the full report here. (May 2022)
- Executive Order 14017 on America’s Supply Chains - 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. As part of our vital mission to protect and promote public health, FDA plays a critical role in this effort, including by overseeing the regulation of a majority of the Nation’s medical and food products. On February 24, 2021, President Biden signed Executive Order 14017 to secure America’s critical supply chains. The Executive Order directed the Administration to: (1) 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 and active pharmaceutical ingredients (API); and (2) submit sectoral supply chain assessment reports within one year of the date of the order, including a report on supply chains for the public health and biological preparedness industrial base and a report on supply chains for the production of agricultural commodities and food products.
- 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