Adverse Events Home Page
IND Decision Tool
IND Exemption Form
Highlights of FDA History
What FDA Regulates
FDA Authorities
FDA Centers
Clarifying the "new" in IND
Assessing Preclinical Data
Properties of the Study Drug
How the Data is Used
IND Submission
IND Holder Reponsibilities

Clarifying the “New” in IND

One of the FDA’s primary mechanisms for ensuring the safety of research subjects is through Investigational New Drug (IND) filing requirements. The term IND can be misinterpreted, leading researchers to conclude that if the drug they are studying is already approved by the FDA, it is not a “new” drug needing a IND application to be filed. THIS IS INCORRECT!

There are many other facets to consider whether a drug being investigated is “new”. The FDA approves a drug as safe with any or all of the following specifications (these indications are spelled out in the Investigational Brochure or in the PDR):

  • Route of administration
  • Dose/duration
  • Form of the drug (e.g. capsule vs. tablet)
  • For specific medical conditions
  • With concomitant medications or medical conditions

A study that uses a “new” aspect of the drug's use (i.e. different indication, dose, population, etc.) usually requires the filing of an IND.

For any investigator-initiated biomedical research being conducted, the researcher should consult with OCR (Office of Clinical Research) to determine whether or not an IND application needs to be filed.

In attempting to determine whether or not an IND is required, the following points are considered:

Preclinical Data
Properties of the Study Drug
How the Data Will Be Used