Pediatric Product Development

Many of FDA's initiatives around pediatrics have aimed to improve medical product research in children. This is making for safer and more effective treatments.  For further information about pediatric product development, please contact pedsdrugs@fda.hhs.gov or 301-796-2200.  

Best Pharmaceuticals for Children Act (BPCA)

BPCA provides an incentive of additional marketing exclusivity to sponsors who voluntarily complete pediatric clinical studies outlined in a Written Request issued by FDA.

Pediatric Research Equity Act (PREA) 

PREA gives FDA the authority to require pediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group.  The goal of the studies is to obtain pediatric labeling for the product.

Pediatric Review Committee (PeRC)  

PeRC is an internal committee established under the Food and Drug Administration Amendments Act (FDAAA) to carry out activities related to BPCA and PREA.

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Off-Patent Studies under BPCA

BPCA provides a mechanism for the National Institutes of Health (NIH) to identify drugs no longer under patent that need to be studied in children due to a lack of dosing, safety or efficacy data.  FDA works with the NIH to ensure that data from the clinical studies is considered for labeling modification.

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Pediatric Guidances

Statutes and Regulations

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Pediatric Reports of Interest

Includes congressionally mandated reports & others

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Historical References

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Page Last Updated: 02/15/2018
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