Best Practices for Communication Between Investigational New Drug Sponsors and Food and Drug Administration During Drug Development; Draft Guidance for Industry and Review Staff; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled "Best Practices for Communication Between IND Sponsors and FDA During Drug Development." The purpose of this 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, which may facilitate earlier availability of safe and effective drugs to the American public.