Appendix C
The Critical Path to New Medical Products*

On March 16, the Food and Drug Administration (FDA) released a report addressing the recent slowdown in innovative medical therapies submitted to the FDA for approval, “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.” That report describes the urgent need to modernize the medical product development process—the Critical Path—to make product development more predictable and less costly.

According to Acting FDA Commissioner Lester M. Crawford, “A new focus on updating the tools currently used to assess the safety and efficacy of new medical products will very likely bring tremendous public health benefits.” Because of its unique vantage point, the FDA can work with outside experts in companies, patient groups, and the academic community to coordinate, develop, and/or disseminate solutions to Critical Path problems, to improve the efficiency of product development industry-wide. Through this initiative, the FDA will take the lead in the development of a national Critical Path Opportunities List, to bring concrete focus to these tasks.

We will develop this list through extensive consultation with private and public stakeholders. To this end, we are establishing an open public docket to obtain input on the most pressing scientific and/or technical hurdles causing major delays and other problems in the drug, device, and/or biologic development process, as well as proposed approaches to their



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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Appendix C The Critical Path to New Medical Products* On March 16, the Food and Drug Administration (FDA) released a report addressing the recent slowdown in innovative medical therapies submitted to the FDA for approval, “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.” That report describes the urgent need to modernize the medical product development process—the Critical Path—to make product development more predictable and less costly. According to Acting FDA Commissioner Lester M. Crawford, “A new focus on updating the tools currently used to assess the safety and efficacy of new medical products will very likely bring tremendous public health benefits.” Because of its unique vantage point, the FDA can work with outside experts in companies, patient groups, and the academic community to coordinate, develop, and/or disseminate solutions to Critical Path problems, to improve the efficiency of product development industry-wide. Through this initiative, the FDA will take the lead in the development of a national Critical Path Opportunities List, to bring concrete focus to these tasks. We will develop this list through extensive consultation with private and public stakeholders. To this end, we are establishing an open public docket to obtain input on the most pressing scientific and/or technical hurdles causing major delays and other problems in the drug, device, and/or biologic development process, as well as proposed approaches to their *   From http://www.fda.gov/oc/initiatives/criticalpath/

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary solution. In addition, FDA will make internal changes to intensify its ability to surface and address crucial issues and to support high-priority critical path research efforts. Challenge and Opportunity on the Critical Path to New Medical Products (March 2004) Full Report (PDF) Available: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html White Paper Executive Summary Available: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html#execsummary Critical Path News Release Available: http://www.fda.gov/bbs/topics/news/2004/NEW01035.html