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FDA: How to Talk with Us About INDs

The U.S. Food and Drug Administration’s (FDA) Office of New Drugs has developed an online course entitled "Best Practices for Communication Between FDA and IND Sponsors During Drug Development." Their stated goal is to communicate “best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development.” A more detailed draft guidance document (pdf) of the same name is also available.

While IND filings may be second nature to experienced drug developers, the guidance offered in this short course will benefit most investigators in better navigating the FDA’s IND process, and thereby lead to more rapid clinical testing of candidate therapeutics.


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