FDA Guidance Addresses Drug Safety Evaluation in Pregnancy

Summary: The FDA has new rules to help doctors know if medicines are safe for pregnant women. Right now, many drugs are given to pregnant women even if they weren't fully tested for pregnancy safety during early clinical trials. The new guide tells drug companies how to collect better safety information after a drug is already approved. They will use three main ways to learn more: looking at patient reports, creating pregnancy registries, and checking medical records. This will help doctors and moms-to-be understand any risks much faster.

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