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Guidance on End-of-Phase 2A Meetings

09/26/2008

Federal Register Notice: FDA is making available a draft guidance for industry, End-of-Phase 2A Meetings. It provides information on end-of-phase 2A meetings for sponsors of INDs who seek guidance on employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, disease, placebo) to design trials for better dose response estimation, dose selection, and other appropriate issues. The guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and to improve the quality of drug applications through early meetings with sponsors. To download this guidance, click here. To view this notice, click here.

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