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Challenge and opportunity on the critical path to new medical products

by FDA Center for Drug Evaluation and Research

This white paper by the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) provides analysis of the pipeline problem in innovative medical therapies reaching patients. In the FDA’s view, the applied sciences are not being used to guide the technology development process in the same way that they are accelerating the discovery process. This white paper addresses the growing crisis in moving basic discoveries to the market where they can be made available to patients. It offers a way forward, including examples of agency efforts, and opportunities for future efforts, and calls for a joint effort of industry, academia and the FDA to identify key problems and develop targeted solutions.

Published: 2004
Format: PDF
Length: 38 pages
Type: White paper
Language: English
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