BLA 761108/S-021
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We also remind you that you must submit a REMS assessment when you submit a supplemental application for a new indication for use, as described in section 5051(g)(2)(A) of the FDCA. This assessment should include:
| a) | An evaluation of how the benefit-risk profile will or will not change with the new indication; | |
| b) | A determination of the implications of a change in the benefit-risk profile for the current REMS; | |
| c) | If the new indication for use introduces unexpected risks: A description of those risks and an evaluation of whether those risks can be appropriately managed with the currently approved REMS. | |
| d) | If a REMS assessment was submitted in the 18 months prior to submission of the supplemental application for a new indication for use: A statement about whether the REMS was meeting its goals at the time of that last assessment and if any modifications of the REMS have been proposed since that assessment. | |
| e) | If a REMS assessment has not been submitted in the 18 months prior to submission of the supplemental application for a new indication for use: Provision of as many of the currently listed assessment plan items as is feasible. | |
| f) | If you propose a REMS modification based on a change in the benefit-risk profile or because of the new indication of use, submit an adequate rationale to support the modification, including: Provision of the reason(s) why the proposed REMS modification is necessary, the potential effect on the serious risk(s) for which the REMS was required, on patient access to the drug, and/or on the burden on the health care delivery system; and other appropriate evidence or data to support the proposed change. Additionally, include any changes to the assessment plan necessary to assess the proposed modified REMS. If you are not proposing REMS modifications, provide a rationale for why the REMS does not need to be modified. | |
If the assessment instruments and methodology for your REMS assessments are not included in the REMS supporting document, or if you propose changes to the submitted assessment instruments or methodology, you should update the REMS supporting document to include specific assessment instrument and methodology information at least 90 days before the assessments will be conducted. Updates to the REMS supporting document may be included in a new document that references previous REMS supporting document submission(s) for unchanged portions. Alternatively, updates may be made by modifying the complete previous REMS supporting document, with all changes marked and highlighted. Prominently identify the submission containing
U.S. Food and Drug Administration
Silver Spring, MD 20993
www.fda.gov
Reference ID: 5019210
