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NEW QUESTION 48
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

• A. Allow the auditor access to the room and records due to the current audit.
• B. Deny the auditor access to the room and retrieve only the requested records.
• C. Allow the auditor accompanied access to the room to retrieve the records.
• D. Deny the auditor access to the room and records due to confidentiality concerns.

Answer: C

NEW QUESTION 49
Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

• A. Marketing materials
• B. Safety issues
• C. Clinical trial data
• D. Intellectual properly

Answer: B

NEW QUESTION 50
Which of the following is NOT required to be included in a marketing application?

• A. Final printed label
• B. Quality, safety, and efficacy Information
• C. Administrative forms
• D. Evidence of fee payment

Answer: D

NEW QUESTION 51
Which of the following is the PRIMARY purpose of an audit report?

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

Answer: A

NEW QUESTION 52
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