USA – « Research Investigational New Drug Applications – What You Need To Know » June 25, 2019 Issue

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 (eCTD) requirements apply for an investigational new drug (IND) application.

A commercial IND is one for which the sponsor (usually a corporate entity) intends to commercialize the product by eventually submitting a marketing application. In this case, the sponsor should select “Commercial IND” on FDA Form 1571 Field 6B.  FDA may also designate an IND as commercial if it is clear that the sponsor intends for the product to be commercialized at a later date…