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Clinical Pharmacology Pediatrics Program

Promoting the development of safe and effective new drugs and biologics to optimize the health and wellbeing of the pediatric population across all stages of maturation and development.

Overview

The Clinical Pharmacology Pediatrics Program is within the Office of Clinical Pharmacology (OCP) in the Office of Translational Sciences (OTS). The program includes a cadre of regulatory scientists with expertise in pediatric clinical pharmacology, molecular biology, and health science. The program brings together multidisciplinary experts to promote the application of fundamental clinical pharmacology principles and tools to advance the development of new therapeutic drugs and biologics for the pediatric population. The graphic below illustrates the three components of the program: stakeholder engagement, regulatory reviews and policy development, and education programs.

A diagram of the three main components of the clinical pharmacology pediatric program: Stakeholder Engagement; Regulatory Reviews & Policy Development; and Education Programs. The full text of this graphic is repeated in the text of this webpage.

Stakeholder Engagement

Lead and participate in multidisciplinary collaborations, partnerships, and outreach to stimulate advancements and innovations in the development of therapeutics for pediatric use. 

Key activities include the following:

  • Identify and address critical gaps in scientific knowledge through pediatric-related research, policy development, and peer-reviewed publications
  • Share regulatory insights and subject matter expertise with national and international partners on cutting-edge scientific innovation, streamlining of therapeutic development, and advancements in the field of clinical pharmacology and regulatory science
  • Keep the public informed of clinical pharmacology initiatives, understand concerns with therapeutic developments for pediatric use, and encourage participation in research 

Regulatory Reviews and Policy Development

Advise and support multidisciplinary teams in the conduct of FDA’s regulatory reviews and policy development activities to enhance availability of safe and effective therapeutics for the pediatric population.

Key activities include the following:

  • Provide consultation for regulatory reviews of new drug applications (NDAs) and biological license applications (BLAs) to help ensure that pediatric ontogeny and the potential effect of intrinsic and extrinsic factors on disease, treatment response, and therapeutic dosages are integrated into the overall clinical pharmacology assessments of therapeutics for pediatric use 
  • Review initial pediatric study plans (iPSPs), lead a renewed focus on pediatric developmental safety and the application of new approach methodologies to pediatric drug development, and engage in projects associated with molecular targets relevant to pediatric cancers
  • Provide clinical pharmacology subject matter expertise for the development of regulatory guidance documents to inform stakeholders of FDA’s current thinking on issues or topics germane to pediatric clinical pharmacology
  • Lead and participate in policy development to help guide therapeutic development and regulatory decision-making

Education Programs

Provide state-of-the-art education to support professional development, stimulate intellectual curiosity, and garner public interest in advancing the field of pediatric clinical pharmacology.

Key activities include the following:

  • Develop, conduct, and oversee educational outreach activities—including workshops, symposia, conferences, webinars, lecture or seminar series, newsletters, and presentations—to diverse audiences on a global scale 
  • Direct and participate in educational programs including Advanced Pharmacy Practice Experiential pharmacy student rotations; undergraduate, graduate, and postgraduate fellowships; visiting associates and visiting scientist; and faculty sabbaticals
  • Support public health through the training and recruitment of regulatory science professionals who will make a career in drug development

Questions?

For more information, please contact us at Pedsclips@fda.hhs.gov.

Explore More About

Our Program - see highlights of our work in publications by the Associate Director for Pediatrics: Gilbert J. Burckart, Pharm.D.

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