FDA Issues New Guidance for IND Sponsors

In late December the FDA issued a new guidance, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The purpose of the guidance is to “describe 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.” The hope is the guidance facilitates an earlier availability of safe, effective and high-quality drugs to the American public, including biosimilars.

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