FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological products in some circumstances and examines the specific ethical and scientific considerations that may impact this decision.

FDA states that they are addressing the challenges of including pregnant women in investigational research to promote maternal/fetal health and informed prescribing decisions during pregnancy.

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