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)
- 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)
- MCM-related legal and policy presentations, publications and Q&As
- MCM regulatory science presentations
Other FDA publications
- Report to Congress: Generating Antibiotic Incentives Now (PDF, 545 KB), February 2018 - HHS released a report to Congress on progress made in facilitating the development and approval of new antibacterial and antifungal drugs, implementing stewardship programs to ensure their judicious use and assessing the impact of the Generating Antibiotic Incentives Now (GAIN) provisions on promoting the pipeline of antibacterial and antifungal drugs. Also see: FDA reports on its progress advancing policies for developing next generation antibiotics and FDA Office of Antimicrobial Products Research Activities
- FDA's Predictive Toxicology Roadmap (PDF, 2.2 MB), December 2017 - FDA's Toxicology Working Group outlined a new plan to expand the agency's predictive toxicology toolbox, and reduce reliance on animal testing for tox studies
- 2016 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals (PDF, 663 KB), December 2017 - The 2016 report shows that antimicrobial sales decreased from 2015 to 2016, with domestic sales and distribution of all antimicrobials decreasing by 10 percent and domestic sales and distribution of medically important antimicrobials decreasing by 14 percent. In previous years (between 2009 and 2015), overall sales volumes increased annually.
- 2015 National Antimicrobial Resistance Monitoring System (NARMS) Integrated Report, including interactive data displays, November 2017
- FDA Science Moving Forward (PDF, 1.4 MB - July 2015), a report highlighting advances that FDA has made since the Science Board’s 2007 report FDA Science and Mission at Risk (PDF, 737 KB - ARCHIVED).
- Biosafety and Biosecurity in the United States fact sheets (2014 - ARCHIVED)
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
- PHEMCE Multiyear Budget FY 2017 – 2021 (PDF, 2.1 MB), published by HHS ASPR, May 2019 - FDA-specific information begins on page 31.
- Global Health Security Strategy (PDF, 416 KB), released by the White House in May 2019 - The Strategy defines the actions the Administration will take to prevent, detect, and respond to infectious disease threats, whether naturally occurring, accidental, or deliberate.
- 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
- National Biodefense Strategy (PDF, 919 KB), from the White House, September 2018 - also see National Security Presidential Memorandum and Statement from the President on the National Biodefense Strategy and National Security Presidential Memorandum
- 2017-2018 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan (SIP) (PDF, 986 KB), published by HHS ASPR, December 2017 - more about the PHEMCE SIP
- 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
- CDC and USDA released the first Select Agent Program Annual Report (June 2016) - see also: Safeguarding Deadly Pathogens and Poisons (blog post from CDC), and a CDC infographic about select agents (PDF, 1.2 MB)
- Project BioShield Annual Reports to Congress, published by HHS ASPR
- PHEMCE Enterprise Review materials, HHS ASPR, 2010