Safety The sponsor has considered the relevance The sponsor’s considerations for the RMP of all safety considerations response has may be raised raised in the Nonclinical and Clinical been noted. by the Evaluation Reports. All of the clinical nonclinical and evaluator comments relevant to the RMP clinical have been addressed. The sponsor does not evaluators believe that any nonclinical safety issues and/or the have been raised that would result in Nonclinical and further revisions to the RMP. Clinical Evaluation Reports respectively. It is important to ensure that the information provided in response to these includes a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, please provide information that is relevant and necessary to address the issue in the RMP. Any ASA The sponsor has updated the RMP to This is updates should comply with the current ASA format and considered be provided in has assigned a version number. acceptable in the current ASA the context of format. this application. The ASA should The sponsor has updated the RMP to As above. be assigned a comply with the current ASA format and version has assigned a version number. number. The sponsor A revised HCP training program The original should supply presentation, based on a similar training sponsor all of the program offered in the US and Canada, as submission
Safety considerations may be raised by the nonclinical and clinical evaluators and/or the Nonclinical and Clinical Evaluation Reports respectively. It is important to ensure that the information provided in response to these includes a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, please provide information that is relevant and necessary to address the issue in the RMP. The sponsor has considered the relevance for the RMP of all safety considerations raised in the Nonclinical and Clinical Evaluation Reports. All of the clinical evaluator comments relevant to the RMP have been addressed. The sponsor does not believe that any nonclinical safety issues have been raised that would result in further revisions to the RMP. The sponsor’s response has been noted. Any ASA updates should be provided in the current ASA format. The sponsor has updated the RMP to comply with the current ASA format and has assigned a version number. This is considered acceptable in the context of this application. The ASA should be assigned a version number. The sponsor has updated the RMP to comply with the current ASA format and has assigned a version number. As above. The sponsor should supply all of the A revised HCP training program presentation, based on a similar training program offered in the US and Canada, as The original sponsor submission
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