Scientific Publications by FDA Staff

Birth Defects Res A Clin Mol Teratol 2014 Oct;100(10):806-10

Highlights from the United States Food and Drug Administration's public workshop on the development of animal models of pregnancy to address medical countermeasures in an "at-risk" population of pregnant women: Influenza as a case study.

Williams D, Basavarajappa MS, Rasmussen SA, Morris S, Mattison D

The U.S. Food and Drug Administration (FDA) and other federal agencies partner to ensure that medical countermeasures (e.g., drug therapies and vaccines) are available for public health emergencies (FDA, 2014). Despite continuing progress, providing medical countermeasures and treatment guidelines for certain populations (e.g., pregnant women) is challenging due to the lack of clinical and/or animal data. Thus, a workshop was convened to discuss animal models of pregnancy for the evaluation of disease progression and medical countermeasures. Birth Defects Research (Part A), 2014. (c) 2014 Wiley Periodicals, Inc.