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                Pediatrics

Pediatrics

                        FDA Perspectives on Pediatric Health
          Pediatric Medical Product Safety
          Pediatric Ethics
          International Collaboration / Pediatric Cluster
          Pediatric Science and Research Activities
          Medical Products for Newborns
          Pediatric Labeling Changes
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          Pediatrics
          Pediatric EthicsPediatrics Pediatric Ethics
  
  	
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    PrintThe FDA works to assure all clinical trials involving FDA-regulated products and enrolling children are scientifically sound and ethically appropriate. The agency works closely with stakeholders to address ethical issues raised in the development and use of medical products in newborns, infants, children and adolescents. For example, the agency:

Supports medical product reviews by evaluating ethical issues in pediatric medical product development
	Assesses reports of potential pediatric ethics violations in FDA-regulated research from external stakeholders
	Trains staff across the agency and provides expertise to external stakeholders on ethical issues in pediatric medical product development
	Explores ethical issues raised by pediatric studies required or requested under federal laws including the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act**Additional safeguards for children in clinical investigations**

Under FDA regulations, children are afforded additional protections when participating in clinical trials. These regulations restrict the level of risk to which children may be exposed unless those risks are justified by the prospect of direct clinical benefit. The regulations also require investigators to obtain caregiver permission and, when appropriate, child assent to participate in research.

**Additional resources**

Additional Safeguards for Children in Clinical Investigations
	Draft guidance: Ethical Considerations for Clinical Investigations of Medical Products Involving Children
	Snapshot of draft guidance and podcast (podcast transcript)
	Draft guidance: Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections
	Draft guidance: Informed Consent Information Sheet
	Draft guidance: General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products
	Clinical Trials and Human Subject Protection
	Office for Human Research Protections

                                                                                  Content current as of:
      01/16/2024Pediatrics

          
                        FDA Perspectives on Pediatric Health
          Pediatric Medical Product Safety
          Pediatric Ethics
          International Collaboration / Pediatric Cluster
          Pediatric Science and Research Activities
          Medical Products for Newborns
          Pediatric Labeling Changes
          Reports, Statistics, Reviews and Databases
 
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