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The goal of the Medical Countermeasures Initiative (MCMi) regulatory science program is to develop the tools, standards, and approaches to assess medical countermeasure safety, efficacy, quality, and performance and to help translate cutting-edge science and technology into innovative, safe, and effective medical countermeasures (MCMs).

FDA scientists regularly present at conferences and other events.  Where available, we have provided event materials related to MCM regulatory science below. Learn where we'll be presenting in the future on our news and events page.

Presentations

• May 26, 2021: FDA's Medical Countermeasures Initiative (MCMi) – Strengthening Regulatory Science to Further the Development of Medical Countermeasures
  2021 FDA Science Forum - poster presented by the OCET MCMi regulatory science team

• September 12, 2019: Strengthening Regulatory Science to Advance the Development of Medical Countermeasures for Emerging Infectious Diseases (657, KB)
  2019 FDA Science Forum - slides presented by CAPT Tracy MacGill, PhD  

• March 2-3, 2019: Strengthening Regulatory Science to Support Development and Approval of Medical Countermeasures for Biological Threats (PDF, 576 KB)
  Chemical and Biological Terrorism Defense (Ventura, CA), hosted by Gordon Research Conferences  – poster presented by Robert Orr

• August 27-10, 2017: Measuring the Success of the UTMB-FDA Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (PDF, 833 KB)
  Poster presented at the Military Health System Research Symposium

• December 4-8, 2016: Strengthening Regulatory Science to Support Development and Approval of Medical Countermeasures for Ebola (PDF, 1.4 MB)
  Hemorrhagic Fever Viruses (Santa Fe, NM), hosted by Keystone Symposia - poster presented by CAPT Tracy MacGill, PhD

• November 18, 2016: Challenges in the Development of Medical Countermeasures (PDF, 293 KB)
  Biology of Anthrax workshop - slides presented by CAPT Tracy MacGill, PhD  

• March 1, 2016: MERS-CoV Regulatory Questions (PDF, 112 KB)
  Clinical Trials for Vaccines and Therapeutics, Robert Fisher, PhD

• February 10, 2016: The FDA Animal Rule (PDF, 179 KB)
  ASM Biodefense and Emerging Diseases Meeting - slides presented by CAPT Tracy MacGill, PhD

• January 7, 2016: FDA MCM regulatory science presentations. PHEMCE Stakeholders Workshop (PDF, 1.6 MB)
  FDA regulatory science slides, including MCM regulatory science overview, CBER MCM research and case study on anthrax vaccine shelf life, determining MCM dose in special populations (CDER), and infectious disease diagnostics and FDA-ARGOS database (CDRH)

• January 6-7, 2016: Monitoring and Assessment: FDA's Role (PDF, 231 KB)
  Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop

• January 6-7, 2016: Beyond The Last Mile: MCM Monitoring and Assessment during Public Health Emergencies (PDF, 525 KB)
  Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop    

• November 9-10, 2015: Transcripts - Clinical Trial Designs for Emerging Infectious Diseases Workshop [ARCHIVED]
  FDA and partners held a workshop to discuss clinical trial designs for emerging infectious diseases   

• FDA's 2015 Office of Regulatory Science and Innovation Science Symposium [ARCHIVED]
  FDA's Office of Regulatory Science and Innovation (ORSI) held a one-day Science Symposium on April 27, 2015 to highlight research underway in its extramural programs to advance FDA's Regulatory Science Initiative

• October 21, 2014: Challenges in Approval of New Treatments in the Biodefense World (PDF - 233KB) [ARCHIVED] (PDF, 233 KB)                                            Presentation to Safety Pharmacology Society 14th Annual Meeting, by CAPT Tracy MacGill, PhD

Related Links

• 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report - 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.
• Scientific Publications by FDA Staff
• MCMi Regulatory Science Symposium (ARCHIVED) (2012-2014)
• MCMi Events Archive
• MCM-Related Legal and Policy Presentations, Publications and Q&As
• Publications and Reports
• 2017 FDA Science Forum Webcast recordings