Regulatory Affairs Certification (RAC) Practice Exam

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All of the following would require a Type B Meeting request EXCEPT:

  1. Special Protocol Assessment (SPA).

  2. Pre-IND.

  3. End of Phase 2.

  4. Pre-BLA.

The correct answer is: Pre-IND.

A Type B Meeting is a formal interaction between a sponsor and regulatory authorities to discuss development programs, often to address pressing issues related to drug development, as these meetings can significantly influence the trajectory of a product. The Pre-Investigational New Drug (Pre-IND) meeting does not require a Type B Meeting request because it is typically meant for sponsors to seek advice and gain preliminary insights to help shape their forthcoming IND submission. It is more informal and is aimed at clarifying any questions before entering the formal regulatory process. The intent is to facilitate open dialogue, but it does not carry the same weight or protocol as Type B meetings. Conversely, other scenarios such as Special Protocol Assessments, End of Phase 2 meetings, and Pre-Biologics License Application meetings focus on critical elements in the drug development process where regulatory considerations are paramount. These meetings have particular significance and usually require a Type B request to appropriately frame the discussion around essential protocol concerns and ensure that both the sponsor and the regulatory agency are aligned on development plans and expectations for moving forward.