The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings.
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FDA’s Center for Drug Evaluation and Research (CDER) recently accepted a new submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This submission is the first artificial intelligence-based and digital health technology-based project and the first proCenter for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence
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