RAC-USRegulatory Affairs Certification (RAC) US
100 Questions and Answers Experienced specialists selected 100 questions for this exam. All answers are verified to ensure correctness.
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RAC-US Online Practice Questions and Answers
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?
A. Product stability
B. Product registration
C. Product formulation
D. Product requirements
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. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
B. No action is required since it is an off-label use.
C. Advise the senior management to send a "Dear Dr." letter.
D. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
A. Ask the vendor to take responsibility.
B. Document and perform audits.
C. Request an inspection from a regulatory authority.
D. Request documentation from the sub-contractor.
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