FDA: New Guidance on Investigational New Drug Applications (INDs)

The US Food and Drug Administration FDA has published a draft Guidance for Industry on Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND for comment purposes.

The guidance describes when an IND is required, specific situations in which an IND is not required, and a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND regulations. It is intended to assist clinical investigators and sponsors in determining whether human research studies must be conducted under IND.

FDA regulations describe three categories of clinical investigations that are exempt from the IND requirements, if certain criteria are met. Those criteria are defined in detail in the draft guidance. The three categories are:

  • Certain Research Involving Marketed Drug Products
  • Bioavailability or bioequivalence (BA/BE) studies using unapproved versions of approved drug products
  • Radioactive drugs (drugs containing unstable isotopes) for certain research (when they are generally recognized as safe and effective)

The Draft Guidance does also list a set of Frequently Asked Questions regarding the use of the IND regulations and describes the process for addressing inquiries concerning the application of the IND requirements.

Compiled by
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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