FDA Pregnancy Categories



FDA Pregnancy Categories





The Food and Drug Administration has established five categories to indicate the potential for a systemically absorbed drug to cause birth defects. The key differentiation among the categories rests upon the degree (reliability) of documentation and the risk-benefit ratio.


Category A:

Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters.

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Jul 20, 2016 | Posted by in ONCOLOGY | Comments Off on FDA Pregnancy Categories

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