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FDA Rethinking Weight Loss Standards: A Test Case for Patient-Focused Drug Development

This article was originally published in RPM Report

Executive Summary

The Center for Drug Evaluation & Research is working with George Washington University as a “neutral convener” to rethink weight loss drug development standards. That may make for an unexpected legacy from the wave of failed weight loss candidates from 2010: a whole new approach to drug development guidance from FDA.

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Commissioner Hamburg on R&D Productivity

The following is an excerpt from FDA Commissioner Margaret Hamburg’s keynote address to the Food & Drug Law Institute annual meeting in Washington April 4.

A Case Study in Regulatory Innovation: Pharmacogenomics at FDA

FDA’s idea to encourage “voluntary” submission of pharmacogenomic data started slow—but the program has paid significant dividends for the agency. In addition to building knowledge and advancing the use of PKG in drug regulation, it has also won over industry and become a case study to support broader funding of regulatory science.

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