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  1. Development & Approval Process (Drugs)

Maternal Health Product Development

Maternal Health Product Development

The Maternal Health Team (MHT) is part of the Division of Pediatric and Maternal Health (DPMH) which is a consultative division located within the Office of New Drugs (OND). MHT is responsible for developing regulations, guidance documents, and procedures related to gathering and communicating data on the use of drugs during pregnancy and lactation. MHT works with the OND review divisions and other Center for Drug Evaluation and Research (CDER) offices.  MHT focuses on issues concerning postmarketing studies for pregnant and lactating women; the language contained in the pregnancy, lactation, and females and males of reproductive potential subsections of labeling; and the development of pregnancy prevention and planning risk management strategies.

Developmental Resources

Maternal Health Guidance Documents


Contact DPMH

Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs
Division of Pediatric and Maternal Health
10903 New Hampshire Avenue
Silver Spring, MD 20993
Main Line: 301-796-2200
Fax: 301-796-9744

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