QUESTION: 1

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?

Adverse event reports
Clinical experience
Clinical investigations
Literature search

Answer(s): C

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During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate FIRST step for the company to take?

Contact the regulatory authority to argue that its conclusions are wrong.
Contact the regulatory authority to discuss its findings.
Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
Wait for the regulatory authority's final publication on its findings.

Answer(s): B

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QUESTION: 3

According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

3
5
10
15

Answer(s): B

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QUESTION: 4

A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

Plasma fractionation
Product distribution
Individual plasma donation
Plasma pooling

Answer(s): B

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Pass your Regulatory Affairs Certification (RAC) US exam with these free Actual Questions and Answers

QUESTION: 1

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QUESTION: 4

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