This guidance provides recommendations about how and when to include pregnant women in drug development clinical trials for drugs and biological products based on the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this subject. Specifically, this guidance supports an informed and balanced approach to gathering data on the use of drugs and biological products during pregnancy through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk. This draft guidance is intended to serve as a focus for continued discussions among various entities such as the Agency, pharmaceutical manufacturers, the academic community, institutional review boards (IRBs), and others who are involved with the conduct of clinical trials in pregnant women.