Module 5 Presentations

18/07/2024

Information Amendments

Information Amendments (21 CFR 312.31) are any amendment to the IND with information essential to the investigational product that is not within the scope of a protocol amendment, safety report or annual report. Information Amendments may include new: ● Toxicology information; ● Chemistry information; and/or ● Other technical information or a report regarding discontinuation of a clinical or non-clinical investigation.

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Information Amendments (cont’d.) 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:

New CMC information should be identified in the submission cover letter as:

• A statement of the nature and purpose of the amendment; • An organized submission of the data in a format appropriate for scientific review; and

“ Information Amendment: Chemistry, Manufacturing, and Control”

New Toxicology information should be identified as:

“Information Amendment: Pharmacology-Toxicology”

• A request for FDA’s

Discontinuation of a clinical or non-clinical investigation, should be identified as:

comment, if the sponsor desires FDA to comment on the information amendment.

“Information Amendment: Clinical”

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