IND Information Amendments

When do you need to make an information amendment for an Investigational New Drug (IND) application?

Information amendment is any amendment to an IND application with information essential to the investigational product that is not within the scope of protocol amendments, safety reports, or annual reports. For example, information amendments to IND applications may include new toxicology, chemistry, or other technical information or a report regarding discontinuance of a clinical or non-clinical investigation.

Information amendments to an IND application should be submitted as necessary but, to the extent feasible, not more than every 30 days.

Required documents and information

Any information amendment submitted under an IND application is required to bear prominent identification of its contents (e.g., “Information Amendment: Chemistry, Manufacturing, and Control”, or “Information Amendment: Pharmacology-Toxicology”, or “Information Amendment: Clinical”), and to contain the following:


Use the form below or contact CTSI Regulatory Specialist Sheila Austin, (352) 273-8702, for assistance with the IND process and forms. We are happy to answer any questions you might have.

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