FDA Issues Guidance for Industry Assessing Reproductive Toxicity
May 23, 2019
(Medscape) – Cancer is diagnosed relatively rarely in pregnant women. It occurs in about 1 in 1000 pregnancies. Treating cancer in pregnant women is complex. The goal is to optimize cancer treatment while minimizing harm to the fetus. This can be tricky and largely depends on the treatment options, the impact of treatments on pregnancy, and the gestational age of the fetus. To assist in evaluating reproductive toxicity and the effect on the development of the embryo-fetus, the US Food and Drug Administration (FDA) has announced final guidance for industry on reproductive toxicity testing and labeling recommendations for oncologic drugs.