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How did FDA determine the areas of focus for the Critical Path Opportunities List? How did we determine which projects would be on the list?

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How did FDA determine the areas of focus for the Critical Path Opportunities List? How did we determine which projects would be on the list?

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The List was developed through extensive consultation with private and public stakeholders, including 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. We also asked our reviewers for their views on the scientific and technical hurdles they see industry-wide. The Opportunities List is the compilation of what we learned. The list released today is meant to spur a continued dialog among industry, academia, patient and professional groups and government organizations about the research priorities that need to be accomplished in our effort to modernize the medical product development process. We believe it is crucial to build a national infrastructure to support and continually improve the Critical Path Initiative, therefore, we must reach beyond specific opportunities and build collaborations to work together to encourage continued development of t

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