Emergency Preparedness and Response

Pediatric Medical Countermeasures

Resources for Public Health Preparedness

Due to physiological differences, children’s responses to drugs may differ from those of adults. Developing products to diagnose and treat children poses many challenges, especially when developing medical countermeasures (MCMs), such as vaccines, drugs, and medical devices, that may be used in a public health emergency.

Public health emergencies could include the accidental or deliberate release of a biological, chemical, radiological, or nuclear (CBRN) substance, newly recognized naturally occurring infectious diseases, and natural disasters.

FDA is working to foster the development of safe and effective MCMs that may be needed during public health emergencies, including those for use in pediatric populations and young adults (less than 21 years of age). 

The resources below include information about these MCMs, and some of the scientific, ethical, and regulatory issues related to the development of pediatric MCMs and public health preparedness.

FDA Contacts

teddy bear with toy stethoscope and maskFDA Medical Countermeasures Initiative (MCMi)
AskMCMi@fda.hhs.gov

FDA Office of Pediatric Therapeutics (see Pediatrics)
OPT@fda.hhs.gov

Aysha Akhtar, MD
Medical Officer, Office of Counterterrorism and Emerging Threats, FDA
aysha.akhtar@fda.hhs.gov

Robert “Skip” Nelson, MD, PhD
Senior Pediatric Ethicist, Office of Pediatric Therapeutics, FDA
Robert.Nelson@fda.hhs.gov

NOTE: Non-FDA links below are included for reference, and do not necessarily reflect FDA's positions or opinions. Consistent with FDA website policies and disclaimer, reference in any referred (linked) website to commercial products, services, manufacturers, or companies does not constitute an endorsement by the U.S. government, the Department of Health and Human Services, or FDA.

FDA Pediatric Pages

Public information from FDA about pediatric topics and MCMs, including workshops, Advisory Committee meetings, presentations, and events

  • Pediatric Counter-Terrorism Measures
    From FDA's Center for Drug Evaluation and Research (CDER), this page lists approved MCMs regulated by CDER and other information related to emergencies including anthrax, chemical agents, and radiation
  • Pediatrics
    Comprehensive science and research information, not limited to MCMs, from FDA’s Office of Pediatric Therapeutics on pediatric product development, including issues related to labeling, ethics, safety, and other regulatory considerations
  • Pediatric Medical Devices
    Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. Some products are designed specifically for children, while others are borrowed from adult applications or produced for more general use
  • Pediatric Product Development
    Many of FDA's initiatives around pediatrics have aimed to improve medical product research in children. Learn more about pediatric product development

Ethical Considerations for Pediatric MCM Research

Information from FDA and other sources about ethical considerations for pediatric populations in MCM research and product development

Additional Resources

Resources from other sources, including other government agencies

Page Last Updated: 11/01/2016
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