FDA Publishes Final Guidance on Determining Whether Human Research Studies Can Be Conducted Without An IND

FDA Publishes Final Guidance on Determining Whether Human Research Studies Can Be Conducted Without an IND

FDA’s recently published guidance provides an overview of IND requirements and details specific situations in which an IND is not required. This guidance is the finalized version of a draft guidance published in October 2010. 

The guidance reviews the general requirement that human research studies be conducted under an IND when all of the following conditions exist:

  • The research involves a drug as that term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(g)(1)).
  • The research is a clinical investigation as defined in the IND regulations (21 CFR 312.3).
  • The clinical investigation is not otherwise exempt from the IND requirements in Part 312.

The guidance then describes categories of investigations exempt from IND requirements.  For exempt studies involving marketed drug products, the guidance clarifies what is meant by a drug that is “lawfully marketed” in the US.  It notes that use of the marketed version of the drug in exactly the same dosage form, dosage levels, and patient populations described in the marketed labeling for the product is not required; rather, the exemption allows for changes to the marketed product that do not increase risk. Exemptions for bioavailability/bioequivalence studies in humans are also discussed.

The guidance also describes the conditions under which radioactive and cold isotopes can be used for certain research without an IND. Specific issues concerning the application of IND regulations with respect to endogenous compounds, live organisms, cosmetics, foods, and research with noncommercial intent are also addressed.

The guidance is available online at:


Please contact Sterling if you would like to discuss how this guidance impacts your submissions for IRB review.  



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