2021 Updated Verified Pass RAC-US Exam - Real Questions & Answers
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NEW QUESTION 10
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
- A. Fishbone analysis
- B. Failure modes, effects, and criticality analysis
- C. Fault tree analysis
- D. Quality by design analysis
Answer: B
NEW QUESTION 11
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. Negotiate with colleagues and the authority to find a better time.
- D. Arrange for an inspection without all intended personnel.
Answer: C
NEW QUESTION 12
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?
- A. Regulatory agency
- B. Quality assurance
- C. Quality improvement
- D. Clinical affairs
Answer: B
NEW QUESTION 13
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Assess the potential safety risk.
- B. Withdraw the affected product from the markets.
- C. Notify the global regulatory authorities.
- D. Send a "Dear Dr." letter to customers.
Answer: C
NEW QUESTION 14
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?
- A. Scope and level of detail
- B. Expiration date
- C. Revision history
- D. Relevance to regulations
Answer: D
NEW QUESTION 15
A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?
- A. Notify the regulatory authority.
- B. Inform the production team.
- C. Recommend an immediate product recall.
- D. Compare the approved text with the product label
Answer: D
NEW QUESTION 16
Which of the following claims would classify an apple as a drug?
- A. "It will make you look younger."
- B. "It will prevent colds."
- C. "It will satisfy hunger."
- D. "It will whiten teeth."
Answer: B
NEW QUESTION 17
The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?
- A. Review alt distribution records and complaints reported in Country Y.
- B. Prepare the legal team in Country Y for possible litigations.
- C. Draft a formal letter to customers in Country Y about this recall.
- D. Initiate a mandatory recall of the product in Country Y.
Answer: A
NEW QUESTION 18
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. Promote off-label use to a carefully selected patient population.
- B. Delay product launch until required studies are completed.
- C. Label the product for use in appropriate populations.
- D. Educate patients and healthcare providers on how to use the product
Answer: A
NEW QUESTION 19
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?
- A. Prepare regulatory submissions that detail the medical device's change in materials.
- B. Review the content of change and supporting data for the equivalency with the current material.
- C. No action is needed in this situation.
- D. Write a memo to file since the change does not impact product safety and effectiveness.
Answer: B
NEW QUESTION 20
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. Request documentation from the sub-contractor.
- B. Request an inspection from a regulatory authority.
- C. Ask the vendor to take responsibility.
- D. Document and perform audits.
Answer: D
NEW QUESTION 21
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Regulatory authority
- B. Distributor
- C. Consumer
- D. Manufacturer
Answer: D
NEW QUESTION 22
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?
- A. Isolation and purification
- B. Physical processing and packaging
- C. Introduction of the API starting material
- D. Production of Intermediate(s)
Answer: B
NEW QUESTION 23
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
- A. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
- B. Consult with the legal department to discuss the best course of action.
- C. Review the regulatory guidelines to determine how to proceed.
- D. Request a meeting with the regulatory authority to discuss the application.
Answer: D
NEW QUESTION 24
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. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- B. Wait for the regulatory authority's final publication on its findings.
- C. Contact the regulatory authority to discuss its findings.
- D. Contact the regulatory authority to argue that its conclusions are wrong.
Answer: C
NEW QUESTION 25
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?
- A. Ask that the regulatory authority provide the actual product subject to the complaint.
- B. Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release. - C. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
- D. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.
Answer: C
NEW QUESTION 26
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. Develop a better brand-name drug in the same class.
- B. Develop a generic version of the drug.
- C. Explore litigation strategy for patent infringements on the drug.
- D. Conduct a Phase III study for a new unrelated indication of the drug.
Answer: B
NEW QUESTION 27
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