Pregnancy Not a Bar to Trial Participation, FDA Says

April 10, 2018

(MedPage Today) – Pregnant women can be enrolled in clinical trials when adequate preclinical studies have already been done and the drug could provide otherwise unavailable benefits to the mother or fetus, the FDA suggested in draft guidance issued Monday. The guidance also recommended that pregnant women be enrolled in postmarketing trials if “adequate nonclinical studies (including studies on pregnant animals) have been completed, and there is an established safety database in nonpregnant women from clinical trials and preliminary safety data from the medical literature and/or other sources regarding use in pregnant women.”

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