RAC-GS Online Practice Questions and Answers

Which term does NOT describe the same concept as the others?

A. Biosimilars

B. Follow-on protein products

C. Monoclonal antibody

D. Subsequent entry biologics

A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of the SOP Is MOST important to consider?

A. Expiration date

B. Relevance to regulations

C. Revision history

D. Scope and level of detail

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.

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.

At a recent scientific meeting,Company Y had two booths:

At one booth,Company Y provided brochures on a completed Phase II study.

In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed products.

A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

A. Acknowledge receipt of the letter in a written response but do nothing further.

B. Inform the legal department of the letter and discuss how to respond.

C. Inform Company X that it has no right to send such a letter and do nothing further.

D. Inform the local regulatory authority of the letter and discuss how to respond.

A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?

A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.

C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.

During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

A. ISO 14971 risk analysis

B. Failure mode and effect analysis

C. Fault tree analysis

D. Hazard and operability study

An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?

A. Stop product manufacturing.

B. Establish validation procedures.

C. Assess the impact of the changes.

D. Review the stability data for the changes.

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

As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

A. Site license

B. Product license

C. Import license

D. Export license