USFDA issue new draft Guidance on inclusion of pregnant women in clinical trials

Comments and suggestions regarding this draft document should be submitted within 60 days of publication

This guidance provides recommendations about how and when to include pregnant women in drug development clinical trials for drugs and therapeutic 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 This draft guidance is intended to serve as a focus for continued discussions among various entities such as the Agency, pharmaceutical manufacturers, the academic community,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.

This guidance discusses the scientific and ethical issues that should be addressed when considering the inclusion of pregnant women in drug development clinical trials. From a scientific and ethical standpoint, the population of pregnant women is complex based on the interdependency of maternal and fetal well-being, and the need to take into consideration the risks and benefits of drug therapy to both woman and fetus (American College of Obstetricians and Gynecologists 2015). The scientific and ethical issues discussed in this guidance apply both to clinical trials that enroll pregnant subjects and to clinical trials that allow enrolled subjects who become pregnant to remain in the trial.

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