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News and Press: Policy News

FDA Releases White Paper on the Speed of Drug Discovery and Development

Monday, August 31, 2015   (0 Comments)
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The FDA discusses the speed of drug discovery and development in a white paper, titled “Targeted Drug Development: Why Are Many Diseases Lagging Behind?” The white paper briefly describes “the state of scientific knowledge and its effect on drug development in four key disease areas other than cancer and HIV/AIDS”—Alzheimer’s disease, diabetes, rare diseases, and hepatitis C. The report outlines FDA actions to accelerate drug development, such as by allowing the use of surrogate endpoints and through efficient clinical trial design

In an associated blogpost, Dr. Robert Califf, the FDA’s new Deputy Commissioner for Medical Products and Tobacco, highlighted the agency’s unparalleled speed in approving new drugs and reaffirmed its continued willingness to work with other stakeholders to foster innovation. He noted that regulation and involvement in the final stages of drug development can only go so far in improving the situation. What drives advancement is the earlier stages of scientific discovery and biomarker development, and the FDA is also actively involved in encouraging this innovation.

Each of the four disease states discussed in FDA’s white paper points out that FDA has been able to make incremental progress despite imperfect understanding of the diseases. Thus, legislation that gives FDA additional ways to do what it has already done (which could be seen as supporting the 21st Century Cures legislation now passed in the U.S. House) should be encouraged.

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