Is your Study IND Exempt?

Check the DailyMed database for approved indications of the drug/biologic you are studying, if applicable.

The FDA IND regulations can be reviewed at 21 CFR 312.2(b). The criteria for IND Exempt Category #1, the most commonly used IND Exempt Category, are summarized below.

IND Exempt Category #1: Lawfully Marketed Drugs or Biologics

1. The drug or biologic is lawfully marketed (NDA, ANDA, BLA, OTC Monograph) as a drug product in the United States.
2. The research is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug.
3. The research is not intended to support a significant change in the advertising for the product.
4. The research does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product.
5. The research is conducted in compliance with the marketing limitations described in 21 CFR §312.7.

If there is uncertainty about whether the exemption criteria above are met, the potential sponsor-investigator can seek advice from FDAConsults or the FDA on the applicability of the IND regulations (§ 312.2(e)).

Other IND Exemption Categories include:

• Category #2: Serological Tests (21 CFR 312.2(b)(2))
• Category #3: Placebos (21 CFR 312.2(b)(5))
• Category #4: Bioavailability/Bioequivalence Studies (21 CFR 320.31(b) and (d))
• Category #5: Radioactive Drugs for Research Use (21 CFR 361.1)
• Category #6: Cold Isotopes for Research Use (FDA enforcement discretion)

The sponsor-investigator of a clinical investigation of a drug or biologic is responsible for making the initial determination of whether the investigation meets the criteria for an IND exemption.  

• Answer the questions in the IND Decision Tool, with particular attention to requirement #3. (Note: this IND Decision Tool is currently undergoing updates; please check back soon for the updated version.)
• For assistance with the initial determination, see the FDA Guidance Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted without an IND.

UCSF IRB will confirm the validity of the sponsor-investigator's determination during the IRB review process.

Your IRB submission should include the following:

• IND Decision Tool (currently undergoing updates)
• Documentation used to support or confirm any IND Exempt criteria
• Email guidance provided by UCSF Regulatory Support staff regarding IND exemption, if applicable
• Documentation of any official guidance provided by FDA indicating that an IND application is not required (less common)

If the IRB does not agree with the sponsor-investigator's rationale for IND exemption, an IND application must be submitted to FDA’s CDER (Center for Drug Evaluation and Research) or CBER (Center for Biologics Evaluation and Research).