Requirement for information amendment. A sponsor shall report in an information amendment essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report. Examples of information requiring an information amendment include:
New toxicology, chemistry, or other technical information; or
A report regarding the discontinuance of a clinical investigation.
Content and format of an information amendment. An information amendment is required to bear prominent identification of its contents (e.g., “Information Amendment: Chemistry, Manufacturing, and Control”, “Information Amendment: Pharmacology-Toxicology”, “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.
If the sponsor desires FDA to comment on an information amendment, a request for such comment.
When submitted. Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than every 30 days.
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