[Jan 15, 2022] Get New RAC-GS Practice Test Questions Answers
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NEW QUESTION 57
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase III clinical trials
- B. Phase I clinical trials
- C. Phase I and II clinical trials
- D. Pre-clinical studies
Answer: A
NEW QUESTION 58
Which of the following claims would classify an apple as a drug?
- A. "It will make you look younger."
- B. "It will satisfy hunger."
- C. "It will whiten teeth."
- D. "It will prevent colds."
Answer: D
NEW QUESTION 59
A company establishes a new medical device indication for its consumer disposable products. The
regulatory affairs professional is asked to give a 30-minute training session on these products to sales
representatives. Which of the following subjects is the MOST important to discuss?
- A. Regulatory application summary
- B. Safety-related reporting
- C. Risk management process
- D. Labeling
Answer: D
NEW QUESTION 60
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left
alone in the records room. The records room contains information on all products produced by the
contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?
- A. Allow the auditor accompanied access to the room to retrieve the records.
- B. Deny the auditor access to the room and retrieve only the requested records.
- C. Deny the auditor access to the room and records due to confidentiality concerns.
- D. Allow the auditor access to the room and records due to the current audit.
Answer: A
NEW QUESTION 61
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.
Answer: B
NEW QUESTION 62
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory
affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
- A. Prepare documents for the files.
- B. Communicate with the relevant internal departments.
- C. Request a permanent waiver from the new regulation.
- D. Contact the trade association for advice.
Answer: B
NEW QUESTION 63
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. Abort the product launch.
- B. Inform the regulatory authorities.
- C. Correct the label text.
- D. Delay the start of product production.
Answer: B
NEW QUESTION 64
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?
- A. Adverse event reports
- B. Clinical investigations
- C. Clinical experience
- D. Literature search
Answer: B
NEW QUESTION 65
Company X encounters challenges in the global life cycle management of its medical devices. Which of
the following Is MOST appropriate for improving product life cycle management?
- A. Utilize the STED template to complete global requirements.
- B. Identify countries where special requirements exist during the product development phase.
- C. Initiate a global submission process after all submission data are finalized.
- D. Plan regulatory approval update meetings with senior management and stakeholders.
Answer: B
NEW QUESTION 66
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a
holiday season when most of the staff Is not available. What is the MOST practical approach to this
dilemma?
- A. Insist that key personnel be available for the inspection.
- B. Inform the authority that the time is not suitable and request a new time
- C. Arrange for an inspection without all intended personnel.
- D. Negotiate with colleagues and the authority to find a better time.
Answer: D
NEW QUESTION 67
A regulation change is imminent and may require further non-clinical testing on a product currently in
Phase III clinical trials. What is the most appropriate action to take FIRST?
- A. Obtain a copy of the proposed regulation and analyze the impact.
- B. Consult with the company's legal department regarding options.
- C. Inform the company's senior management and arrange an emergency meeting
- D. Arrange for additional testing of the product at the testing facility.
Answer: A
NEW QUESTION 68
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. Previous actions taken by regulatory authorities on similar products
- B. Capacity of the manufacturing facilities to fully produce the new product
- C. Regulatory requirements for labeling and packaging
- D. Potential clinical sites for the Phase III clinical trial
Answer: A
NEW QUESTION 69
Which of the following changes to a drug product is MOST likely to be implemented without prior
regulatory authority approval?
- A. Deleting an ingredient of the drug product
- B. Introducing a new analytical method
- C. Deleting a drug substance
- D. Strengthening a precaution to the product labeling
Answer: D
NEW QUESTION 70
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. Product distribution
- B. Plasma fractionation
- C. Plasma pooling
- D. Individual plasma donation
Answer: A
NEW QUESTION 71
A company's product was approved by a regulatory authority with the condition that further studies must
be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the
LEAST effective way to achieve this goal?
- A. Educate patients and healthcare providers on how to use the product
- B. Label the product for use in appropriate populations.
- C. Delay product launch until required studies are completed.
- D. Promote off-label use to a carefully selected patient population.
Answer: D
NEW QUESTION 72
During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?
- A. All senior management from the main office
- B. As many as required by international standards
- C. The minimum number of attendees necessary to address the issues
- D. As many as government attendees
Answer: C
NEW QUESTION 73
In addition to protection, what parameters MUST be considered when selecting the primary package (or a
product?
- A. Volume and material
- B. Compatibility and safety
- C. Efficacy and material
- D. Safety and efficacy
Answer: B
NEW QUESTION 74
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?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: C
NEW QUESTION 75
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. Training program for sales people
- C. Service operation procedures .
- D. Written procedure for product traceability
Answer: B
NEW QUESTION 76
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. Explore litigation strategy for patent infringements on the drug.
- B. Conduct a Phase III study for a new unrelated indication of the drug.
- C. Develop a generic version of the drug.
- D. Develop a better brand-name drug in the same class.
Answer: C
NEW QUESTION 77
A superiority advertising claim for a product versus its competitor's product can only be made under which
of the following circumstances?
- A. Results of adequate, well-controlled comparative clinical trial show the product is superior.
- B. In vitro studies show the product to be superior.
- C. Government survey data indicate the product is superior.
- D. Results of a three-year, post-market patient survey indicate the product is superior.
Answer: A
NEW QUESTION 78
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your
company?
- A. Train employees on all regulatory compliance processes using state-of-the-art systems.
- B. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Develop documented procedures for regulatory compliance processes and train personnel.
- D. Train all new employees on regulatory compliance processes and assign a mentor to them.
Answer: C
NEW QUESTION 79
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