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NEW QUESTION 42
During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?

A. As many as government attendeesB. All senior management from the main officeC. As many as required by international standardsD. The minimum number of attendees necessary to address the issues

Answer: D

 

NEW QUESTION 43
Which of the following situations does NOT require rapid communication to regulatory authorities?

A. A major safety finding from a newly completed animal carcinogenicity studyB. A clinically important increase in the rate of occurrence of an "expected." but serious
ADRC. A lack of efficacy with a medicinal product used in treating a life-threatening diseaseD. A statistically significant increase in the number of deaths in an animal dose finding study

Answer: B

 

NEW QUESTION 44
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

A. The manufacturer's experience level with the type of IVD medical device is limited.B. The device incorporates well-established technology that is already present in the market.C. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.D. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.

Answer: A

 

NEW QUESTION 45
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. Deny the auditor access to the room and records due to confidentiality concerns.D. Allow the auditor accompanied access to the room to retrieve the records.

Answer: D

 

NEW QUESTION 46
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