Which of the following is false regarding meeting minutes for formal meetings related to biological products regulated by CBER?

The correct answer regarding the false statement about meeting minutes for formal meetings related to biological products regulated by CBER is that the statement suggesting that for input on additional issues not addressed at the meeting, the requester should submit a response to the FDA meeting minutes is misleading.

In formal meetings with the FDA, particularly those concerning biological products, the minutes are intended to document the discussions and outcomes of the meeting. While it is true that stakeholders may have the opportunity to provide additional comments or feedback after the meeting, this typically comes in the form of a separate formal communication rather than as a direct response to the meeting minutes. Meeting minutes serve a different purpose—they are a record of what transpired during the meeting and should encapsulate the key topics discussed as well as the attendees.

On the other hand, meeting minutes being publicly published is a requirement, as transparency is key in regulatory processes. Including all attendees and their affiliations in the minutes is essential for accountability and clarity on who participated in the discussions. Similarly, reflecting the key topics discussed is fundamental to accurately represent the meeting’s content and decisions made during the proceedings.

Thus, option B does not align with the established protocols concerning follow-up communication after such meetings, making it the false statement in this context.