Regulatory Affairs Certification (RAC) Practice Exam

Which one of the following is NOT an example of a type B meeting with the FDA?

1. PreIND meetings

2. Critical path meetings

3. End of Phase 2 meetings

4. PreNDA meeting

The correct answer is: Critical path meetings

The correct choice identifies Critical Path meetings as not being classified as a type B meeting with the FDA. Type B meetings are specifically designated for discussing important issues related to the development of drugs and biologics. They typically include meetings such as pre-Investigational New Drug (PreIND) meetings, End of Phase 2 meetings, and Pre-New Drug Application (PreNDA) meetings, which focus on significant milestones in the development process to ensure that sponsors are aligned with regulatory expectations. Critical Path meetings, on the other hand, refer to FDA's initiative to facilitate the development of innovative products by providing guidance and support to address the scientific, regulatory, and logistical challenges encountered during the drug and biologic development process. These do not fall under the formal classification of type B meetings, as they are broader in scope and encompass various developmental issues rather than specific regulatory decisions. Understanding this classification is important for regulatory affairs professionals as it helps determine the appropriate forums for seeking FDA guidance during different stages of product development.