Pediatric Trials Network

FDA Label Changes

Under the Best Pharmaceuticals for Children Act (BPCA), the PTN works to provide the Food and Drug Administration (FDA) with information to inform label changes with the necessary information to prescribe the most appropriate doses of the medications to children. As a result of research conducted through the BPCA program, led by the PTN, the following label changes have been made:

  • Acyclovir
  • Ampicillin
  • Caffeine
  • Clindamycin (2)
  • Diazepam
  • Doxycycline
  • Levetiracetam
  • Lisinopril
  • Lithium
  • Lorazepam
  • Mercy babyTAPE
  • 2D and 3D Mercy TAPE
  • Meropenem
  • Propylthiouracil
  • Pralidoxime
  • Rifampin
  • Sodium nitroprusside
  • Fluconazole

REFLECTIONS ON PEDIATRIC CLINICAL RESEARCH

The Pediatric Trials Network (PTN) partnered with the International Children’s Advisory Network (iCAN) to produce an anthology that highlights iCAN members’ perspectives on the pediatric clinical research process. A formal publication will eventually be produced as a way of engaging families in the clinical research process. Take a look at some of the submissions received thus far.

 

Results At-A-Glance

The Pediatric Trials Network works to make medication safer and more effective for all children. As part of that work, we share what we learn with all stakeholders through result summaries. We appreciate every family who participates in research and makes this work possible.

Evidence Into Practice
The leader in pediatric research of off-patent drugs

The PTN provides pediatricians, researchers, and regulators with new information on how children respond to medications. Studies are conducted primarily with off-patent drugs that are lacking data on safety, efficacy, and dosing in pediatric populations. The primary goal is to generate the data necessary to produce evidence-based clinical practice guidelines.