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  1. CDER Offices and Divisions

Division of Pediatrics and Maternal Health

Who We Are

The Division of Pediatrics and Maternal Health (DPMH) is located in the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM). DPMH is a consultative division comprised of Regulatory Project Managers and Clinical Reviewers which make up the Maternal Health Team (MHT) and Pediatrics Team. DPMH works with drug review divisions and other Center for Drug Evaluation and Research (CDER) offices.

What We Do

DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and improve safety data collection and product labeling for pregnant and lactating individuals.

The MHT is responsible for developing regulations, guidance documents, and procedures related to gathering and communicating safety data on the use of prescription drugs during pregnancy and lactation. The MHT focuses on issues concerning:

  • review of safety protocols for pregnant and lactating individuals
  • analysis of data from postmarketing safety studies in pregnant and lactating individuals
  • language contained in the pregnancy, lactation, and females and males of reproductive potential subsections of labeling
  • the development of pregnancy prevention and planning risk management strategies
  • assessment of clinical trial protocols that include pregnant and lactating individuals

The Pediatrics Team works with drug review divisions to develop strategies for clinical trials in children, and answer scientific questions related to pediatric issues. The Pediatrics Team works closely with the Office of Pediatric Therapeutics (OPT) to present pediatric-focused safety reviews at the Pediatric Advisory Committee. The Pediatrics Team also collaborates with National Institutes of Health (NIH) in studying and improving labeling of off-patent drugs in pediatrics.

The Pediatrics Team focuses on issues concerning:

  • review of pediatric protocols
  • analysis of data from pediatric clinical trials
  • language in the pediatric section of labeling including the handling of protected pediatric information
  • preparation of materials for the Pediatric Review Committee (PeRC)
  • internal education on pediatric issues, the development of guidance documents and procedures related to the conduct of pediatric trials and the incorporation of the relevant data into product labeling

Contact Us

Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs
10903 New Hampshire Avenue
Silver Spring, MD 20993
email: CDER Pediatric Team



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