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FDA guidance on journal reprint dissemination remains virtually unchanged from December draft.

Executive Summary

JOURNAL ARTICLES DETAILING EFFICACY STUDIES USED FOR PRODUCT APPROVAL may be reprinted and distributed by manufacturers, FDA says in a final guidance document that remains virtually unchanged from a draft published in December. According to an Oct. 8 Federal Register notice announcing availability of the guidance, "if the article contains effectiveness rates, data, analyses, uses, regimens or other information that is different from approved labeling, the reprint should prominently state the difference(s), with specificity, on the face of the reprint."
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