The FDA typically issues a new guidance when the agency is seeing errors in submissions and a lack of understanding in industry and academia. Most recently, the agency observed these trends regarding when and why the academic research community and industry must prepare an Investigational New Drug (IND) application before studies of a drug or biologic can begin in human subjects. In response, FDA released a new guidance document in October 2010 entitled “Investigational New Drug Applications – Determining Whether Human Research Studies Can Be Conducted without an IND.” The document totals just 19 pages.
Clients in our regulatory consulting & writing practice have told us that the new guidance provides an understanding of:
- Three characteristics of research studies that create an IND requirement
- Six criteria that must be met for a clinical investigation to be IND-exempt
- When and if studies on healthy volunteers or studies using only a few subjects require an IND
- When studies conducted outside the U.S. require an IND
Our clients also found the “Frequently Asked Questions” at the end of the guidance extremely valuable.
After reading the new guidance you should be able to create a checklist and determine whether your study requires an IND. Spend the time, read the guidance, and make a plan.