Pediatrics and Maternal Health

The Division of Pediatrics and Maternal Health 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.

Maternal Health

• Pregnancy Registry Listing (Office of Women’s Health)
• Clinical Trials in Pregnant Individuals (Information on Enrollment of Pregnant Individuals in Clinical Trials)
• Post-Approval Pregnancy Safety Studies
• Maternal Health Guidances
  • Clinical Lactation Studies: Considerations for Study Design
  • Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format
• Public Meetings and Webinars:
  • • Optimizing the Use of Postapproval Pregnancy Safety Studies Workshop Sept. 18-19, 2023
    • Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation FDA Virtual Webinar 10/27/2022.
    • Pharmacokinetic Evaluation in Pregnancy Workshop May 16-17, 2022
    • Pregnancy and Lactation Medication Information for the Healthcare Provider FDA Virtual Webinar 5/11/2022.
    • Pregnancy and Lactation Labeling Rule (PLLR) Risk Communication Advisory Committee Meeting March 5 and 6, 2018.
    • Evaluation of the Safety of Drugs and Biological Products used during Lactation Workshop April 27 and 28, 2016.
    • Study Approaches and Methods to Evaluate the Safety of Drugs and Biologic Products During Pregnancy in the Post-Approval Setting May 28-29, 2014.

Pediatrics

• PREA Noncompliance Letters
• Pediatric Summaries, Full Reviews, Statistics & Pediatric Exclusivity Determinations
• Pediatric Labeling Changes Information Database (PREA/BPCA/Pediatric Rule)
• Pediatrics Guidances
  • Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act
  • Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations
  • Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans
  • Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling
  • Rare Pediatric Disease Priority Review Vouchers
  • FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act
  • ICH-E11 Clinical Investigation of Medicinal Products in the Pediatric Population
  • ICH-E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric  Population
  • General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and  Biological Products
  • General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
  • Pediatric Information Incorporated into Human Prescription Drug and Biological Products Labeling 
  • Nonclinical Safety Evaluation of Pediatric Drug Products
• Off-Patent Studies under BPCA
• Statutes and Regulations
• Pediatric Review Committee (PeRC)
• Historical References
• Resources
  • Pediatric Advisory Committee
  • Pediatric Counter-Terrorism Measures
  • Pediatric Therapeutics
  • Children's Health - Consumer Updates
  • National Institute of Child Health and Human Development

Contact the Division of Pediatrics and Maternal Health

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