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  1. MCM Issues

Pediatric Medical Countermeasures

FDA activities to help foster development of pediatric MCMs to respond to CBRN threats and emerging infectious diseases in pediatric populations

teddy bear with stethoscope and mask

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

FDA Medical Countermeasures Initiative (MCMi)
Office of Counterterrorism and Emerging Threats

FDA Office of Pediatric Therapeutics (also see Pediatrics)

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 Guidance

FDA Pediatric Pages

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

Ethical Considerations for Pediatric MCM Research

Additional information from FDA and other sources about ethical considerations for pediatric populations in MCM research and product development (also see FDA Pediatric Pages above)

Additional Resources

Resources from other sources, including other government agencies

Pediatric and Pregnancy Resources for Emerging Infectious Diseases

Related Links


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