The Project Orbis working group for each submission will consist of FDA and the participating Project Orbis partners. Once the Project Orbis partners are identified, FDA confirms the global submission plan through the U.S. Sponsors must select at least 2 partners, including the FDA. Sponsors can select the number of partners included in a Project Orbis submission. The FDA then sends a proposal to the project partners to confirm their: Projects selected for Project Orbis have high-impact and clinically significant applications. sponsor can propose an application for Project Orbis. The FDA coordinates the selection of applications for Project Orbis.Įither the FDA or the U.S. Selection of submissions into Project Orbis
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