Research Investigational New Drug Applications – What You Need To Know

Similarities and differences in submission requirements for Commercial and Research IND

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.

An IND is generally considered commercial when the product under investigation is intended to be commercialized at a later date. In this case, the sponsor should select “Commercial IND” on FDA Form 1571 Field 6B.

In comparison, an IND is generally considered research if the product under investigation is not intended to be commercialized at a later date. In this case, the sponsor would select “Research IND” on FDA Form 1571 Field 6B.

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