Regulatory Affairs Certification (RAC) Practice Exam 2026 - Free RAC Practice Questions and Study Guide

A Special Protocol Assessment (SPA) does not require a Type B meeting request because it is a formal agreement between the FDA and a sponsor regarding the design and endpoints of a study intended to support a regulatory submission. SPAs are typically established without the need for an in-person meeting and can be submitted through a written request, allowing sponsors to clarify their plans while avoiding the additional step of scheduling a Type B meeting.

In contrast, a Pre-Investigational New Drug (Pre-IND) meeting, End of Phase 2 meeting, and Pre-Biologics License Application (Pre-BLA) meeting all fall under the Category B meetings that facilitate discussions between the sponsor and FDA. These meetings are designed to allow sponsors to gain guidance on their development programs and regulatory submissions, which may involve complex discussions about drug development plans, specific issues that might arise during clinical trials, and regulatory requirements in preparation for submissions. Thus, these other options necessitate a more interactive dialogue with the FDA, justifying their classification as Type B meetings.