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  1. Center for Drug Evaluation and Research | CDER

Office of Drug Evaluation IV: What We Do

The Office of New Drugs is undergoing a reorganization. This site will be updated in the near future. Please check back often. For more information, please visit Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical QualityUntil this page is updated, please use the current contact information presented on this page or contact druginfo@fda.hhs.gov if you have additional questions.

The Office of Drug Evaluation IV (ODE IV) includes one division: the Division of Pediatric and Maternal Health (DPMH).

The Division of Pediatric and Maternal Health (DPMH) oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population, and improve pregnancy and lactation-related information in product labeling. The vision of DPMH is, "A world where clinically relevant data facilitate quality healthcare decisions for children and women of childbearing potential." DPMH collaborates with stakeholders both inside and outside FDA to develop clinically relevant, evidence-based labeling and other communications that facilitate informed use of medicines in children and women of childbearing potential.

DPMH will be part of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine beginning in mid-March 2020.  For more information, please visit: Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality.