Federal
Information amendments.
21 CFR § 312.31
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21 CFR § 312.31
21 CFR § 312.31
Information amendments.
(a)
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:
(1)
New toxicology, chemistry, or other technical information; or
(2)
A report regarding the discontinuance of a clinical investigation.
(b)
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:
(1)
A statement of the nature and purpose of the amendment.
(2)
An organized submission of the data in a format appropriate for scientific review.
(3)
If the sponsor desires FDA to comment on an information amendment, a request for such comment.
(c)
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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