Research Investigational New Drug Applications – What You Need To Know
Listen now
Description
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.
More Episodes
Considerations for Drug Products that Contain Nanomaterials
Published 05/15/24
Using Bayesian statistical approaches to advance our ability to evaluate drug products
Published 08/18/23