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最新的 RAC Regulatory Affairs Certification RAC-US 免費考試真題:

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 regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
B) Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
C) Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
D) Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

2. A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

A) Scope and level of detail
B) Revision history
C) Expiration date
D) Relevance to regulations

3. Which of the following is the PRIMARY purpose of an audit report?

A) To train sales representatives
B) To carry out a complete review of product applications
C) To document compliance history
D) To define how to prepare new product submissions

4. A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

A) Adverse event reports
B) Clinical investigations
C) Clinical experience
D) Literature search

5. The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

A) The process information and analytical result of Company X API
B) Information deemed appropriate by the regulatory authority
C) The process information and analytical result of Company Y API
D) The process information and the comparative analytical result of APIs from both companies

問題與答案：