Description

The Maternal Health Team (MHT) is part of the Pediatric and Maternal Health Staff located in the Immediate Office of the Office of New Drugs.

Mission

Our mission is to help women and their healthcare providers make well informed medicine choices when medicine is needed during pregnancy or breastfeeding.

Overview

The Maternal Health Team aims to:

• Improve drug labeling information related to the use of drugs during pregnancy and lactation.
• Develop regulations, guidance documents, and procedures related to how drugs are labeled for use during pregnancy and lactation.
• Respond to consult requests from review divisions in the Office of New Drugs related to pregnancy and lactation.
• Encourage research on medicines used by pregnant and breastfeeding women.
• Help women and their healthcare providers make well informed medicine choices when medicine is needed during pregnancy or breastfeeding.

Activities

• Work with other government Agencies on pregnancy and lactation initiatives.
• Developing regulations, guidance documents, and procedures related to the use of medicines during pregnancy and lactation.
• Assessing risks of drug exposure during pregnancy and lactation.
• Identifying special government employees with expertise in human teratology, birth defects, and obstetrical pharmacology.
• Encouraging research in women using medicines during pregnancy and breastfeeding in order to improve drug labeling and evidence-based clinical decision making.
• Responding to consult requests from drug review divisions related to:
  • Pregnancy exposure registries
  • Pregnancy and nursing mothers sections of labeling
  • Pregnancy prevention risk management programs
  • Protocol review for studies in pregnant and lactating women (IND/NDA/Phase IV)
  • Evaluating published case reports/series and epidemiologic studies of possible drug-induced adverse pregnancy outcomes or effects in breast-fed infants.

Announcements

• On May 29, 2008, the FDA published the Proposed Pregnancy and Lactation Labeling Rule. The Proposed Rule will amend current regulations on the format and content of the Pregnancy, Labor and Delivery, and Nursing Mothers subsections of labeling. For more information on the proposed rule, please visit the following website: http://www.fda.gov/CDER/regulatory/pregnancy_labeling/default.htm
  

Contact Us

Team members:
Lisa Mathis, M.D., Associate Director
Karen Feibus, M.D., Medical Team Leader
Richardae (Chardae) Araojo, Pharm.D., Regulatory Reviewer
Leyla Sahin, M.D., Medical Officer
Tammie Howard, RN, MSN, Regulatory Reviewer/Project Manager
Point of Contact: MHT@fda.hhs.gov or 301-796-0700

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