Many of FDA's initiatives around maternal health are aimed to improve data collection in pregnant and breastfeeding women. The Maternal Health Team (MHT) is located within the Division of Pediatric and Maternal Health (DPMH) which is a consultative division in 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. In addition, the MHT can assist the drug review divisions in assessing clinical trial protocols that include pregnant women and lactating women.
The FDA has established several initiatives that focus on pediatrics with a goal of improving medical product research in children. This is making for safer and more effective treatments. The Pediatric Team (PT) is located within the Division of Pediatric and Maternal Health (DPMH) and works in concert with the drug review divisions to develop strategies for the conduct of clinical trials in children and answers to scientific questions related to pediatric issues. By request, the PT can review proposed pediatric protocols, provide additional analysis of data, and recommend language contained in the pediatric section of product labeling, including the handling of protected pediatric information. In addition, the PT can assist the review divisions in the preparation of materials for the Pediatric Review Committee (PeRC). The PT is also responsible for 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.
The Pediatric team works closely with the Office of Pediatric Therapeutics (OPT) to present the pediatric focused safety reviews at the Pediatric Advisory Committee and educate drug sponsors and the public on the requirements for pediatric drug development. The Pediatric team also collaborates with National Institutes of Health (NIH), OPT and the OND review divisions in the study of off-patent drugs in pediatrics.
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