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  1. About MCMi

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

Other FDA publications

  • 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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