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NO.1 A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of
submission.
If there is no response after the deadline, what is the BEST approach?
A. Contact the company legal representative in order to begin legal proceedings to enforce the
regulatory authority's response time.
B. Contact the local political representative and ask for intervention with the regulatory authority to
obtain a decision regarding the submission.
C. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be
made regarding the submission.
D. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any
outstanding questions.
Answer: D

RAC-US Report   RAC-US Resourse   

NO.2 What are the MOST important elements that global regulatory agencies want to know before
approving a new product for sale in their countries?
A. Quality and effectiveness
B. Safety and effectiveness
C. Safety and failure risk
D. Quality and failure risk
Answer: B

RAC-US Edition   RAC-US Trustworthy