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Research Investigational New Drug Applications – What You Need To Know

Research Investigational New Drug Applications – What You Need To Know

Update: 2019-06-25
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FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application.
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Research Investigational New Drug Applications – What You Need To Know

Research Investigational New Drug Applications – What You Need To Know

U.S. Food and Drug Administration, Center for Drug Evaluation and Research