FDA’s Pregnancy Reg Could Be Template For Other Product Risk Descriptions
FDA's proposed regulation for the new format of the pregnancy section of labeling appears to offer firms a useful template for how to structure other risk disclosures about products
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FDA's proposed rule to update the format of the pregnancy and lactation sections of drug labeling does not require the firms collect new data about their products, but the agency is hoping to use various mechanisms to encourage them to do so
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