Which of the following is FALSE regarding regulatory meetings between CBER and sponsors of biological products?

The assertion that meetings between CBER and sponsors of biological products may be electronically recorded is false. While documentation of the discussions can take place, formally recording these meetings is not a standard practice due to regulatory and confidentiality concerns. The focus of these meetings is often to provide clarity, establish expectations, and facilitate dialogue between the agency and the sponsors without the implications that may arise from recorded discussions.

The other options highlight true aspects of these regulatory meetings. Meetings serve to enhance understanding between CBER and sponsors, fostering a collaborative environment aimed at expediting the development of safe and effective biological products. They typically involve a set agenda, ensuring that all relevant topics are covered in an organized manner, thereby maximizing the efficiency and productivity of the discussions. Public participation, while valuable, is not guaranteed in these meetings; they usually take place in a controlled setting focused on the specific sponsor's product, maintaining confidentiality and proprietary information.