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FDA Rx pregnancy labeling guidance under development; public hearing planned.

Executive Summary

FDA Rx PREGNANCY LABELING TASK FORCE PREPARING GUIDANCES on "interpretation of reproductive and developmental toxicity data from animals" and on "interpretation of human exposure data," the agency said in a July 31 Federal Register notice. The agency task force "will also consider other possible actions that may be necessary to make pregnancy labeling content more consistent, informative and accessible," the notice states.

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