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Exam Code: RAC-GS
Exam Name: Regulatory Affairs Certification (RAC) Global Scope
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Exam Code: RAC-US
Exam Name: Regulatory Affairs Certification (RAC) US
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NO.1 In which section of the ICH Common Technical Document will the overview of clinical data
appear?
A. Module 4
B. Module 1
C. Module 3
D. Module 2
Answer: D

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NO.2 You discover that your company's top selling product in the last two years has been used off-
label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first
released to the market. Which of the following is MOST appropriate?
A. File a report to regulatory authorities and advise the marketing department to prevent future off-
label use.
B. Advise the senior management to send a "Dear Dr." letter.
C. No action is required since it is an off-label use.
D. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
Answer: D

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