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Provides information on neonatology considerations raised in the development and use of FDA-regulated products in newborns

Our mission:

To lead the effort to deepen and broaden the therapeutic toolbox for neonatal conditions, with an emphasis on safety, efficacy, and labeling.

What we do:

  • Provide neonatal-perinatal medicine consultations and expertise upon request to any center or office within the FDA related to any stage of neonatal or perinatal product development
  • Provide presentations at internal and external events by invitation; train FDA staff on neonatology considerations in FDA-regulated product development
  • Explore neonatology considerations raised by pediatric studies required under the Pediatric Research Equity Act or requested under the Best Pharmaceuticals for Children Act

Pediatric Progress 1997- Jan 2017 (BPCA + PREA) 708 drugs labeled in pediatrics 46 drugs studied in neonates 35 neonatal label changes 20 indicated for neonates

International Neonatal Consortium (INC)

The Neonatology Team participates in the International Neonatal Consortium (INC), a global collaboration formed to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates.

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