§ 312.31. Information amendments.
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/us/cfr/t21/s§ 312.31·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 53 FR 1918, Jan. 25, 1988; 67 FR 9585, Mar. 4, 2002]
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§ 312.31
Information amendments.
Fed. Reg.×6
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