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How can I learn how to file IND? Any specific contacts at the FDA?

April 26, 2017contacts fda file IND learn

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How can I learn how to file IND? Any specific contacts at the FDA?

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Untested, innovative cell-based therapies requiring submission of an investigational new drug (IND) application prior to commencing a Phase I safety clinical study will be evaluated by FDA’s Center for Biologics Evaluation and Research in the review office of Cellular, Tissue and Gene Therapies. Information on submitting an IND application for a biological product is available online at [http://www.fda.gov/cber/ind/ind.htm]. Additionally, questions regarding IND submissions may be directed to CBER’s Manufacturers Assistance and Technical Training Branch, 800-835-4709 or 301-827-1800.