Drugs

IND Application Reporting: Information Amendments

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.

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:

    • A statement of the nature and purpose of the amendment,

    • An organized submission of the data in a format appropriate for scientific review, and

    • A request for FDA’s comment, if the sponsor desires FDA to comment on the information amendment.

 

Page Last Updated: 10/08/2015
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