VIP Exclusive
Certified Regulatory Affairs Professional (RAC) VIP Practice Exam
CRAP — The RAC (Regulatory Affairs Certification) exam is administered by the Regulatory Affairs Professionals Society (RAPS); it consists of approximately 200 scored multiple-choice questions over 3.5 hours, available in US, EU, Canada, and Global tracks, and uses a scaled scoring system (passing score approximately 500 on a 200–800 scale).
30
Questions
90m
Time Limit
70.00%
To Pass
Question 1 of 30👑 VIP
A pharmaceutical company is developing a new chemical entity to treat a rare lysosomal storage disorder affecting approximately 12,000 patients in the United States. Before filing an NDA, the team wants to secure both market exclusivity and eligibility for tax credits on clinical trial expenses. Which FDA designation should they pursue first, and what market exclusivity period does it confer upon approval?
Questions 2–30 and full explanations are VIP-exclusive.