Research Investigational New Drug Applications – What You Need To Know

FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application.

Source: FDA Center for Drug Evaluation and Research - What's New - April 19, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news