Information amendment

Information amendments are used to inform the FDA of new pharmacology or toxicology data, final non-dinical study reports, new chemistry-manufacturing-control information, or notice of the discontinuation of a clinical study. 

Information amendments Submitted to report new information that would not be included as a protocol amendment or safety report. Examples include the results of animal testing, chemistry, manufacturing, and controls data, reports of completed or discontinued clinical trials, or changes in administrative information. 

Amendments (protocol amendments and information amendments), annual reports... 

CMC information [ 312.23(a)(7)] and informational amendments related specifically to CMC [ 312.31] including product characterization, device information, formulation, labeling, lot release, manufacturing information, shipment of product, source information, specifications, lot release data, stability, sterility, and environmental assessment or claim for exclusion... 

Protocols [ 312.23(a)(6)], protocol amendments [ 312.30], previous human experience [ 312.23(a)(9)], safety reports [ 312.32] and informational amendments related specifically to clinical [ 312.31] including adverse reactions, consent forms, investigator information, general investigational plan, Investigator s Brochures, IRB approval, new protocols, revised protocols, site information, investigator data, CVs, and 1572s... 

The appropriate box(es) briefly describing the submission should be checked in item 11. It is possible that one IND amendment may contain protocol amendments and information amendments. In such a case, the applicable boxes are marked. If the filing is for the initial IND, a response to a clinical hold, an initial or follow-up IND safety report, a response to an FDA request for information, an annual report, or general correspondence, the appropriate box should be checked. Finally, there is a box if the sponsor is requesting reinstatement of an IND that has been withdrawn, inactivated, terminated, or discontinued. 

Having said this, as drug development proceeds and as the scale or production is changed from the pilot-scale production appropriate for the limited initial clinical investigations to the larger-scale production needed for expanded clinical trials, the sponsor should submit information amendments to update the initial information submitted on the chemistry, manufacturing, and control processes with information appropriate to the expanded scope of the investigation. 

As noted previously, the sponsor is required to wait 30 days after the submission of the IND before clinical investigations with the new drug may be instituted. Once the IND is in effect, all additional data and information submitted to that IND will be provided in the form of Protocol and Information Amendments, provided as sequentially numbered serial submissions. 

Information Amendments. 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 or data requiring an information amendment include new toxicology, chemistry, or other technical information or a report regarding the discontinuance of a clinical investigation. Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than every 30 days. 

This chapter has been prepared to describe in some detail the requirements of an IND application. Emphasis has been placed on the different requirements for the study of a drug in a phase 1 situation compared with a more advanced stage of drug research, that is, phases 2 and 3. Information relating to the submission of IND protocol and information amendments and IND annual reports has also been included. Finally, the newest guidance relating to the writing and content for an IB based on the International Conference on Harmonization has also been provided in detail. 

In addition to providing guidance on what CMC safety information should be submitted in IND information amendments, the guidance also provides details on the types of corroborating information that is more appropriately submitted to the IND Annual Report. 

Certain information that traditionally has been submitted in information amendments... 

Chemistry Information Amendment (COMIS term) Informed Consent Document... 

Office of the Inspector General (HHS) Interkantonale Kontrollstelle fur Heilmittel (Switzerland) Clinical Information Amendment (COMIS term) Intramuscular... 

The OLCs should be based on the safety analyses of the plant and its environment in accordance with the provisions made in the design. The OLCs should be determined with due account taken of the uncertainties in the process of safety analysis. The justification for each of the OLCs should be substantiated by means of a written indication of the reason for its adoption and any relevant background information. Amendments should be incorporated as necessary as a result of testing carried out during commissioning [39]. 

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