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FDA SHOULD ALLOW POST-MARKETING SURVEY DATA IN LABELING, LILLY PREGNANCY GROUP SAYS; LILLY HAS PREGNANCY REGISTRIES FOR FOUR PRODUCTS, INCLUDING PROZAC

Executive Summary

Post-marketing surveillance data should be used as a source for expanded pregnancy labeling, Lilly clinical trial psychiatrist Freda Lewis-Hall, MD, suggested at FDA's Sept. 12 public hearing on pregnancy labeling.

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