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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 Medical Product SafetyPediatrics Pediatric Medical Product Safety
  
  	
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    PrintThe growth and developmental changes that occur during childhood can affect the safety and effectiveness of medical products when used in children. The FDA works to ensure pediatric safety is appropriately monitored and assessed in clinical trials conducted to support FDA approval. The safety information obtained from these clinical trials may be limited because the trials may be shorter in duration and may enroll fewer patients relative to when the medical product enters the market and is available for wide use. For this reason, the FDA maintains robust programs and systems for monitoring postmarket safety.

Postmarket safety reviews are particularly important for pediatrics. Pediatric product development studies, other than for vaccines or some childhood illnesses such as otitis media, tend to be small due to the limited number of children available for clinical trial participation. Additionally, once a product is approved for either adults or older children, it is frequently used off-label for younger children or for children with different medical conditions. Pediatric postmarket safety reviews enhance our understanding of the safety of a product and our assessment of the balance of risks and benefits of medical products used in children.

The FDA helps ensure medical products are safe when used in children. For example, the FDA’s Office of Pediatric Therapeutics coordinates the Congressionally-mandated postmarket pediatric-focused safety reviews of drugs, biologics, vaccines and humanitarian device exemption devices studied in the pediatric population. The FDA convenes meetings of the Pediatric Advisory Committee to obtain advice on the safety assessments for these products as needed. If safety concerns are identified, the FDA ensures the medical product labeling contains information about the risks. If an important new safety concern arises during postmarket surveillance, the FDA communicates the information to the public. See FDA Pediatric Safety Communications | FDA for pediatric-specific safety communications.

Safety Reporting

Healthcare professionals, patients, families and manufacturers play a vital role in helping the FDA monitor postmarket safety of medical products. If you suspect that an adverse event is related to an FDA-regulated product, file a report through MedWatch, the FDA’s adverse event reporting system. Detailed information about the product and the patient is imperative to allow the FDA to evaluate the risk.

If you suspect that an adverse event is related to a vaccine, file a report through the Vaccine Adverse Event Reporting System (VAERS).

Safety Information

FDA Pediatric Safety Communications
	Pediatric Advisory Recommendations and Updates
	Pediatric Labeling Changes
	Consumer Updates: Children's HealthSafety Reporting

Medwatch: The FDA Safety Information and Adverse Event Reporting Program
	Vaccine Adverse Event Reporting System (VAERS) (hhs.gov)Safety Databases

FDA Adverse Event Reporting System (FAERS) Public Dashboard | FDA
	About Manufacturer and User Facility Device Experience (MAUDE) | FDAProduct Recalls

Recalls, Market Withdrawals, & Safety Alerts
	Biologics Recalls
	Medical Device Recalls

                                                                                  Content current as of:
      10/16/2023Pediatrics

          
                        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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