One month prior to the anticipated approval date for your product, the marketing application that you submitted has become the subject of an advisory committee meeting. The advisory committee members unanimously vote not to approve your product because of a safety concern. What would be your MOST appropriate response to the regulatory authority's request for additional information?

The most appropriate response in this scenario is to offer to perform an additional analysis for the specific safety concern identified by the advisory committee. This demonstrates a proactive approach to addressing the concerns raised during the advisory committee meeting and shows that the company is committed to ensuring the safety and efficacy of the product. By suggesting to conduct further analysis, you are indicating readiness to collaborate with the regulatory authority and undertake necessary steps to resolve the issues identified.

This response not only acknowledges the safety concern but also opens a pathway for communication and demonstrates a willingness to provide more information that could potentially support the re-evaluation of the product. It shows that the company is taking the advisory committee's feedback seriously and is focused on scientific inquiry to support the safety profile of the product.

Offering no additional information or suggesting to resubmit without further investigation may come across as dismissive of the advisory committee's recommendations, thus potentially jeopardizing future discussions. Similarly, stating that the product will not be approved based on the committee's decision does not contribute to constructive dialogue with the regulatory authority.