Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                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
          Reports, Statistics, Reviews and Databases Home
          Science & Research
          Science and Research Special Topics
          Pediatrics
          Reports, Statistics, Reviews and DatabasesPediatrics Reports, Statistics, Reviews and Databases
  
  	
    Share
    Post
    Linkedin

    Email
    PrintThe FDA tracks information relevant to its efforts to assure that pediatric patients have access to safe and effective medical products. For example, the FDA is required to track and make publicly available certain pediatric information resulting from pediatric clinical trials conducted pursuant to the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003.

Pediatric Labeling Changes

Find pediatric labeling changes and study characteristics data highlighting key pediatric information obtained from studies submitted to the FDA in response to legislative initiatives, including BPCA and PREA.

Reports to Congress

Find the FDA’s reports to Congress about topics relevant to pediatrics, including status updates on implementation of BPCA and PREA.

Pediatric Study Statistics and Reviews

Find statistics pertaining to pediatric study progress, waivers, and deferrals, Written Requests and Pediatric Exclusivity, and access FDA’s reviews of pediatric studies conducted in response to BPCA and PREA.

Pediatric Advisory Committee (PAC) Recommendations and Updates

Find recommendations from the PAC about adverse event reports of postmarket pediatric safety data for certain medical products.

FDA Track

Find statistics for the FDA’s Office of Pediatric Therapeutics’ efforts in outreach, safety measures, and international collaboration.

                                                                                  Content current as of:
      04/14/2022Pediatrics

          
                        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
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop