RAC-US Online Practice Questions and Answers

Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

A. Conduct a Phase III study for a new unrelated indication of the drug.

B. Develop a generic version of the drug.

C. Develop a better brand-name drug in the same class.

D. Explore litigation strategy for patent infringements on the drug.

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. Intellectual properly

B. Clinical trial data

C. Safety issues

D. Marketing materials

In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

A. Potential clinical sites for the Phase III clinical trial

B. Regulatory requirements for labeling and packaging

C. Capacity of the manufacturing facilities to fully produce the new product

D. Previous actions taken by regulatory authorities on similar products

Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

A. Subject is hospitalized due to complications of the product administration.

B. Subject is hospitalized for the purpose of product administration.

C. Subject's hospitalization is due to an unscheduled hip operation.

D. Subject's hospitalization is prolonged during the clinical trial.

A company is developing a new line of products in an area that is new to the company. What is the BEST approach?

A. Ask the trade association representative to provide an overview of the new product area to the marketing team.

B. Obtain competitor research and provide the information to the management team.

C. Obtain regulatory documents and history and provide the information to RandD.

D. Summarize regulatory documents and history and provide the information to the management team.

As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

A. Inform the regulatory authorities.

B. Delay the start of product production.

C. Correct the label text.

D. Abort the product launch.

A global company has obtained a patent in a specific country for a newly marketed product. What would be the BEST advice In order to protect the patent in other countries?

A. Use the Madrid system.

B. Use the community patent system.

C. File patents of interest in target countries.

D. File design patents in target countries.

The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?

A. Transfer the notice of the upcoming international monograph change to QA for further processing.

B. Prepare the international monograph change submission first and then prepare the local change when required.

C. Confirm that the international monograph change is not related to local pharmacopeia.

D. Analyze the impact of the international monograph change on the local pharmacopeia.

According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

A. Class A

B. Class B

C. Class C

D. Class D

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?

A. Contact the regulatory authority to argue that its conclusions are wrong.

B. Contact the regulatory authority to discuss its findings.

C. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.

D. Wait for the regulatory authority's final publication on its findings.