RAC-GS Online Practice Questions and Answers

A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X. where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y. The company is proposing to start marketing the coated device in Country Y. Which regulatory approach should the company propose?

A. Submit the product for review as a pharmaceutical product in Country Y.

B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

C. Apply for review of the additional part of the product as a pharmaceutical product in Country

D. Examine decisions made about similar products in Country Y to propose the classification ofthe product.

Company X and Company Y both have products for the treatment of rare genetic diseases. Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.

What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?

A. Enter into an agreement with Company Y to perform due diligence.

B. Recruit a professional to gather confidential intelligence on Company Y.

C. Request the needed information from the Board of Directors of Company Y.

D. Perform a thorough library search to gather detailed information on Company Y.

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.

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

A. To carry out a complete review of product applications

B. To define how to prepare new product submissions

C. Todocument compliance history

D. To train sales representatives

One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

A. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."

B. "We have no additional informationto provide at this time, but wecan perform an additional analysis for a specific safety concern, if necessary."

C. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."

D. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

A. Allow doctors to use the product for the off-label indication.

B. Communicate with the sales department to stop using the promotional materials.

C. Contact the marketing department to recall the product.

D. Request that doctors stop using the product for the off-label indication.

You discover that your company's top selling product in the last two years has been used off-label. The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

A. Discuss with regulatory authorities to investigate how to have the off-label indication approved.

B. No action is required since it is an off-label use.

C. Advise the senior management to send a "Dear Dr." letter.

D. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.

What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

A. Ask the vendor to take responsibility.

B. Document and perform audits.

C. Request an inspection from a regulatory authority.

D. Request documentation from the sub-contractor.

Why is it necessary to run supplemental safety pharmacology studies?

A. To substitute the utilization of GLP

B. To comply with regulatory authority requirements related to clinical studies

C. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery

D. To provide adverse reaction reports and the results of the statistical data to the regulatory authority

What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A. Safety and failure risk

B. Safety and effectiveness

C. Quality and failure risk

D. Quality and effectiveness