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James T. Cross, MS

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

In their recent commentary, Furberg et al¹ make recommendations to improve Food and Drug Administration (FDA) and current drug safety regulations. The authors fail to address 2 critical points: (1) the need to improve mechanistic assessments of new drug safety prior to FDA approval and (2) the need for sweeping changes in practice of medicine.

Their proposal for empirical determination of drug safety through postmarketing study commitments and for FDA authority over their conduct may improve our long-term understanding of safety. However, this approach assumes that a safety issue has already been identified by the time of FDA approval. Also, it benefits only those who begin using the product after such safety studies are completed, results published, and clinical care modified.

A proposal should underscore the need for more sensitive and diverse biomarkers and surrogate end points for drug safety evaluation during clinical development. We have . . . [Full Text of this Article]

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