Investigational New Drug (IND) Decision Resource
Not sure whether or not you need to file an IND to conduct your
study? Think your study might be exempt?
You're not alone. The language in the Code of Federal Regulations
and the Food and Drug Safety Act is difficult to interpret and often
misunderstood. Many researchers make the mistake of not filing an
IND when by regulation, they are required to do so.
The Office of Human Research at the University of Pennsylvania School of Medicine has developed several resources to assist you with this process:
- IND Decision Tool
- The IND Decision Tool guides you through
a decision tree process
to help determine whether or not you need to file an IND. Use of the IND Decision Tool also can help clarify the conditions in which an IND is typically required.
Begin the IND Decision Tool now
- IND Submission Template
- The IND Submission Template provides essential elements, guidance, and a formatted document in which to prepare an IND submission to the FDA.
IND Submission Template for drugs not yet marketed
IND Submission Template for marketed drugs
- Use this website to learn more about FDA Regulations as they
apply to clinical research investigating the use of drugs.
Begin the tutorial now
All tools and content in this site
are (c) 2003-2005 Trustees of the University of Pennsylvania.
For more information or comments,
please contact us at email@example.com