RAC-GS Online Practice Questions and Answers

Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

A. "Product X is a guaranteed cure for arthritis."

B. "Product X is effective for the treatment of arthritis."

C. "Product X is safe for arthritis and without side effects."

D. "Product X is effective in all patients with arthritis."

After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

A. Add a warning in the IFU.

B. Discontinue the project.

C. Perform another risk-benefit analysis.

D. Redesign the device.

A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?

A. Approved indications of the drug

B. Determination of primary mode of action

C. Determination of product design deliverables

D. Guidance documents for the device

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

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."

The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

A. Production

B. Analytical

C. Quality

D. Regulatory

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.

In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

A. Local reimbursement requirements

B. Service operation procedures

C. Training program for sales people

D. Written procedure for product traceability

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

A clinical study of a drug is completed to support a marketing approval application. According to ICH,how long should a sponsor retain the clinical study essential documents?

A. For at least two years after the last approval of an application in an ICH region

B. Fora minimum of 10 years after completion of the clinical study

C. Three years after the last clinical study site was supplied with investigational drugs

D. Until the product has been discontinued from marketing in all ICH regions

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?

A. Plasma fractionation

B. Product distribution

C. Individual plasma donation

D. Plasma pooling

Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?

A. Active-controlled

B. Cross-over

C. Dose-ranging

D. Placebo-controlled

In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation. However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

A. Discuss with the regulatory apriority and attempt to reach an acceptable solution.

B. Inform the internal departments to redesign the product to comply with this requirement.

C. Inform the regulatory authority that such a requirement is not applicable to the product.

D. Notify senior management that the product cannot be registered.

According to ICH, which of the following components of study information is NOT required in a clinical study report?

A. Randomization scheme and codes

B. Protocol and protocol amendments

C. ListoflECsorlRBs

D. Detailed CVofall investigators