FDA Seeks To Amend Drugs' Pregnancy Labeling

Law360, New York (May 29, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has proposed a change of its prescription-drug-labeling regulations that would require labels to include a summary of the risks of use during pregnancy and breast-feeding.

The proposed revisions would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding or of child-bearing age, the FDA said in a statement Wednesday.

Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient...
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