FDA proposes Rx label revisions for moms

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The FDA on Wednesday announced it is proposing revisions to physician labeling for Rx drugs to include more info about their use by pregnant and/or breast-feeding mothers.

The proposed changes would give physicians more comprehensive information for making prescribing decisions and for counseling mothers and moms-to-be about medications, the agency said in a posting on its Web site.

“With this proposal, FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit,” said Sandra Kweder of the FDA's Center for Drug Evaluation and Research.

The agency is soliciting electronic comments regarding the proposal over the next 90 days via the Federal Documents Management System/eRulemaking portal a www.regulations.govThe FDA said it will carefully consider the comments in preparing a final rule.

More information on the FDA proposal is available at: http://www.fda.gov/cder/regulatory/pregnancy_labeling/default.htm.


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