4 December 2015 - The purpose of the draft guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public.

For more details, go to: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM475586.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery