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RAC Regulatory Affairs Certification VIP Practice Exam
RAC — The RAC (Regulatory Affairs Certification) is issued by the Regulatory Affairs Professionals Society (RAPS) and consists of 150 multiple-choice questions administered over 3 hours, covering regulatory strategy, submissions, labeling, advertising and promotion, compliance and enforcement, clinical and scientific affairs, quality systems, and professional practices; a scaled passing score is required.
30
Questions
180m
Time Limit
75.00%
To Pass
Question 1 of 30👑 VIP
A pharmaceutical company is developing a combination product consisting of a drug pre-filled in a device. During a pre-submission meeting, FDA informs the sponsor that the primary mode of action (PMOA) is attributable to the drug component. Which FDA center will have primary jurisdiction over this combination product, and which regulatory pathway will the company most likely pursue?
Questions 2–30 and full explanations are VIP-exclusive.