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How can I determine if an Investigational New Drug Application (IND) is required for my study?

April 26, 2017application determine drug IND investigational study

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How can I determine if an Investigational New Drug Application (IND) is required for my study?

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The best way to determine if an IND is required for a study is to contact the FDA (http://www.fda.gov/cder/). Please call the CDER (Center for Drug Evaluation and Research) Drug Information main phone number at 301-827-4570.