Publications and Reports
FDA Medical Countermeasures Initiative (MCMi) reports and annual program updates
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MCMi Fiscal Year 2019 Program Update - about this report - download a printable 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
- 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
- MCMi Strategic Plan 2012 to 2016 (PDF, 632 KB - ARCHIVED)
Other FDA publications
- FDA Office of the Chief Scientist reports:
- See our Antimicrobial Resistance Information from FDA page for FDA publications related to AMR
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
- 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