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Pregnancy Labeling: US FDA Ponders Whether Changes Needed To Overcome Risk Misperceptions

Executive Summary

Risk Communication Advisory Committee will opine on impact that Pregnancy and Lactation Labeling Rule has had in conveying safety evidence useful to making prescribing decisions for pregnant patients and whether current labeling language can be improved upon.

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Pregnancy Labeling Needs Clearer, More Consistent Language, US FDA Panel Says

Language used to describe drug effects on pregnancy and lactation is ambiguous, complex and not useful to prescribers, advisors say, also urging FDA to use graphics or rating scales to convey the strength of the animal and human data on use during pregnancy.

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