What should you say if requested additional information to support the safety of your product after an advisory committee meeting votes against approval?

The response stating that you have no additional information to provide but can perform an additional analysis for a specific safety concern, if necessary, is a valid approach to address the situation. This option showcases a willingness to be responsive and responsible by indicating that while there may not be further data at that moment, there is an openness to conduct more focused analyses based on the specific safety concerns raised. This constructive approach aligns well with regulatory expectations and emphasizes a commitment to ensuring the product's safety.

It is important to acknowledge that after an advisory committee has voted against approval, the emphasis should be on understanding their concerns and working collaboratively to address them rather than assuming further data will change the committee's stance without clear guidance on what is specifically needed. Performing targeted analyses can show respect for the committee’s feedback and demonstrate a proactive approach to enhancing the understanding of the product's safety profile. This method can potentially lead to constructive discussions on how to address any outstanding issues identified by the committee.