论文信息 - Postmarketing drug dosage changes of 499 FDA‐approved new molecular entities, 1980–1999

Postmarketing drug dosage changes of 499 FDA‐approved new molecular entities, 1980–1999

Risks and benefits of marketed drugs can be improved by changing their labels to optimize dosage regimens for indicated populations. Such postmarketing label changes may reflect the quality of pre‐marketing development, regulatory review, and postmarketing surveillance. We documented dosage changes of FDA‐approved new molecular entities (NMEs), and investigated trends over time and across therapeutic groups, on the premise that improved drug development methods have yielded fewer postmarketing label changes over time.

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