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                MCM Issues

MCM Issues

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          Pediatric Medical CountermeasuresMCM 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
	
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              teddy bear with stethoscope and maskResources 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 ThreatsAskMCMi@fda.hhs.gov

FDA Office of Pediatric Therapeutics (also see Pediatrics)OPT@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 Guidance

Search for FDA guidance documents
	Guidances and Other Information of Special Interest to MCM Stakeholders (including pediatrics)
	FDA issues two draft guidances for industry to support the approval of pediatric drug products (May 17, 2023)FDA Pediatric Pages

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

Pediatric Medical Countermeasures (drugs)
	From FDA's Center for Drug Evaluation and Research (CDER), this page lists approved MCMs regulated by CDER and other considerations for bioterrorism and radiation emergencies
	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
	COVID-19 Vaccines
	Including information from FDA about vaccines for pediatric populations
	Pediatric Medical Device Development public meeting (Silver Spring, MD and webcast)
	August 13-14, 2018 - To identify strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of pediatric populations
	Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies - workshop materials [ARCHIVED]
	April 13-14, 2016 - Discussion with experts regarding the length of pediatric safety studies, including an exposition of the successes and challenges of long-term safety studies in children, and suggestions for study design and implementation
	2013 Meeting Materials, Pediatric Advisory Committee to the Food and Drug Administration [ARCHIVED]
	September 19-20, 2013 - Meeting transcript and presentations, including a Pediatric Ethics Subcommittee discussion of the ethical issues involved in development of pediatric MCMs
	Workshop presentations: Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures [ARCHIVED]
	February 15-16, 2012 – Public workshop hosted by FDA, featuring science and ethics tracks - agenda and presentationsEthical 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)

Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines
	July 2021 - "Concerned about the dearth of information available on the safety and effectiveness of medical products for pregnant and breastfeeding women, the FDA and many of its regulatory counterparts around the world say it is time to address inadequacies in research through a paradigm shift in the approach to studying medical products in these populations."
	Safeguarding Children: Pediatric Medical Countermeasure Research [ARCHIVED]
	March 2013 – Report from the Presidential Commission for the Study of Bioethical Issues
	Current Ethical and Regulatory Framework for Pediatric Product Development [ARCHIVED] (PDF, 756 KB)
	May 17, 2012 - Presidential Commission for the Study of Bioethical Issues meeting - presentation by Dr. Robert "Skip" Nelson (see next items for additional meeting info.)
	Presidential Commission for the Study of Bioethical Issues - Meeting Nine
	May 17, 2012 - Meeting information, including webcast video, transcripts, presentations and other coverage of pediatric MCM discussions [ARCHIVED]
	Special Considerations for Research with Children - transcript of session [ARCHIVED] (PDF, 122 KB)
	May 17, 2012 - Presidential Commission for the Study of Bioethical Issues meeting – includes FDA presentation by Dr. Robert "Skip" NelsonAdditional Resources

Resources from other sources, including other government agencies

HHS Child and Adolescent Health Emergency Planning Toolkit
	14 million children in the U.S. have special health care needs, and meeting those needs becomes more challenging during disasters. This new toolkit can help health care, public health, and social services professionals meet their disaster health needs (March 2023)
	National Advisory Committee on Children and Disasters (NACCD)
	The Advisory Committee will provide advice and consultation to the HHS Secretary on pediatric medical disaster planning, preparedness, response, and recovery with respect to the medical and public health needs of children in relation to disasters
	Best Pharmaceuticals for Children Act (BPCA) Priority Lists of Pediatric Therapeutic Needs
	Lists organized by therapeutic area, including biodefense research priorities (developed by NIH in consultation with FDA and experts in pediatric research)
	Children in Disasters and Emergencies: Health Information Guide (NIH/NLM)
	A compendium of resources related to medical and public health issues of children in disasters and emergencies; links to journal articles and other materials that may be useful in preparedness, mitigation, response and recovery activities
	Children and Disasters (AAP)
	Information about pediatric disaster preparedness, from the American Academy of Pediatrics
	Caring for Children in a Disaster (CDC)
	Children are more vulnerable than adults in emergency situations; information about how children are different, tools and resources, and specific threats
	Radiation Emergency Medical Management (REMM)
	Treatment and diagnosis information for healthcare providers (including pediatric resources) about radiation emergencies
	Planning for Kids: Preparedness and Pediatrics (CDC)
	Information about a tabletop exercise for first responders, and resources for parents and caregivers
	National Pediatric Readiness Assessment
	For emergency departments: complete this assessment and track your improvement over time
	National Pediatric Disaster Coalition
	The mission of the National Pediatric Disaster Coalition (NPDC) is to advance community preparedness, mitigation, response and recovery for infants, children, and their families in disasters
	In the Event of Bioterrorism: Protecting Families from Deadly Diseases
	Information for parents, from the American Academy of Pediatrics (includes Spanish and audio versions)
	Resilient Children/Resilient Communities Toolbox
	The RCRC Toolbox was developed under a partnership between the National Center for Disaster Preparedness at Columbia University and Save the Children
	Pediatric Medical Countermeasure Roundtable for Health Security Meeting Report (PDF, 436 KB)
	October 13-14, 2010 – Meeting convened by the HHS PHEMCE
	Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the Pediatric Population as a Component of Post-Exposure Prophylaxis (PEP) [ARCHIVED] (PDF, 780 KB)
	October 2011 - Report of the National Biodefense Science Board
	Emergency Preparedness and Response Resources for Maternal and Child Health (MCH) Populations
	June 16, 2015 – Recording of a webinar hosted by the Association of Maternal and Child Health Programs (AMCHP) (1 hour)
	2014-2015 Report of the CHILD Working Group (PDF, 608 KB)
	February 2017 - HHS updates on: behavioral health; medical countermeasures; child physical health, EMS, and pediatric transport; child care, child welfare, and human services; pregnant and breastfeeding women and newborns; and children at heightened risk
	Zika Virus, Still a Threat - Updates and Implementation
	December 13, 2017 - American Academy of Pediatrics (AAP) webinar video recording (54 minutes)
	Pediatric Issues in Disasters (PDF, 6.4 MB)
	February 13, 2018 - ASPR TRACIE webinar materials
	PHEMCE Strategy and Implementation Plan
	From the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) – includes information about pediatric populations
	COVID-19 Resources for Pediatric Healthcare Leaders and Clinicians
	From HHS
	Infant and Young Child Feeding in Emergencies (IYCF-E) Toolkit
	From CDCPediatric and Pregnancy Resources for Emerging Infectious Diseases

From CDC:
	Information about COVID-19 Vaccines for People who Are Pregnant or Breastfeeding
		Clinical Considerations for mpox in Children and Adolescents
		Clinical Considerations for mpox in People Who are Pregnant or Breastfeeding
		Zika virus information for healthcare providers
		Zika and Pregnancy
	Zika Training for Health Care Providers
	Training options for obstetric healthcare providers, pediatricians, and nurses, from CDCRelated Links

Pediatrics
	What are Medical Countermeasures?
	Vaccines for Children - A Guide for Parents and Caregivers

                                                                                  Content current as of:
      06/07/2023
              
              
Health Topic(s)
			  Pregnancy
			    			       			    			       Coronavirus
			       			    			       ZikaMCM Issues

          
                        Advanced Manufacturing
          Antimicrobial Resistance Information from FDA
          Ebola Preparedness and Response Updates from FDA
          FDA/DoD Collaborations
          FDA Mpox Response
          Medical Countermeasure Monitoring and Assessment
          Pediatric Medical Countermeasures
          Preparedness Information for Consumers
          Radiological and Nuclear Emergency Preparedness Information from FDA
          Smallpox Preparedness and Response Updates from FDA
          Zika Virus Response Updates from FDA
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