Division of Pediatric and Maternal Health
About Us
The Division of Pediatric and Maternal Health (DPMH) is located in the Office of New Drugs. DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and to improve pregnancy and lactation-related information in product labeling.
- PREA Noncompliance Letters (PREA Non-compliance letters and the letters from sponsors)
- Pregnancy and Lactation Labeling Rule (PLLR)
- Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)
Maternal Health
- Pregnancy Registry Listing
- Maternal Health Guidance Documents
- Clinical Trials in Pregnant Women
- Post-Approval Studies in Pregnant Women
- Lactation Studies
- FDA Public Meetings of Interest
- Selected Presentations
- Publications
Pediatrics
- Pediatric Summaries, Full Reviews, Statistics & Pediatric Exclusivity Determinations
- Pediatric Labeling Changes Information Database (PREA/BPCA/Pediatric Rule)
- Pediatric Guidance(s)
- Off-Patent Studies under BPCA
- Adult-Related Conditions That Qualify for a Waiver Because They Rarely or Never Occur in Pediatrics
- Statutes and Regulations
- Pediatric Review Committee (PeRC)
- Historical References
Contact DPMH
Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs
10903 New Hampshire Avenue
Silver Spring, MD 20993
Main Line: 301-796-2200
Fax: 301-796-9744