RAC-US Dumps Updated Dec 13, 2021 Practice Test and 100 unique questions
2021 Latest 100% Exam Passing Ratio - RAC-US Dumps PDF
NEW QUESTION 46
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. Hazard and operability study
- B. ISO 14971 risk analysis
- C. Failure mode and effect analysis
- D. Fault tree analysis
Answer: B
NEW QUESTION 47
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. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."
- B. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
- C. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."
- D. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
Answer: C
NEW QUESTION 48
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?
- A. Increase the frequency of monitoring visits.
- B. Terminate the PI and inform the regulatory authorities.
- C. Inform the institution that granted a medical license to the Pi.
- D. Send a letter of complaint to the Ethics Committee that approved the site.
Answer: B
NEW QUESTION 49
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 50
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?
- A. Physical processing and packaging
- B. Production of Intermediate(s)
- C. Isolation and purification
- D. Introduction of the API starting material
Answer: A
NEW QUESTION 51
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. No action is required since it is an off-label use.
- B. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
- C. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
- D. Advise the senior management to send a "Dear Dr." letter.
Answer: C
NEW QUESTION 52
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. Review the stability data for the changes.
- C. Establish validation procedures.
- D. Assess the impact of the changes.
Answer: A
NEW QUESTION 53
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 54
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 55
A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?
- A. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
- B. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.
- C. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
- D. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.
Answer: A
NEW QUESTION 56
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
- A. Product literature
- B. Essential principles
- C. Instructions for use
- D. Risk analysis
Answer: D
NEW QUESTION 57
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. Clinical affairs
- B. Quality improvement
- C. Quality assurance
- D. Regulatory agency
Answer: C
NEW QUESTION 58
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
- A. After the enactment of the regulation, through the industry representative
- B. Before the enactment of the regulation, through formal comments gathering process
- C. Before the enactment of the regulation, through the industry representative
- D. After the enactment of the regulation, through a product-specific meeting
Answer: B
NEW QUESTION 59
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?
- A. Risk management
- B. Risk control
- C. Risk estimation
- D. Risk analysis
Answer: D
NEW QUESTION 60
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?
- A. Proposed dose and volume of administration
- B. Proposed product route and frequency of administration
- C. Biological activity with species and/or tissue specificity
- D. Immunochemical and functional tests
Answer: C
NEW QUESTION 61
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 62
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 4
- B. Module 3
- C. Module 2
- D. Module 1
Answer: C
NEW QUESTION 63
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. Request a meeting with the regulatory authority to discuss 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. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
Answer: A
NEW QUESTION 64
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 the antibiotics 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 as a medical device in Country Y as the product is already marketed in Country X as a medical device.
- B. Apply for review of the additional part of the product as a pharmaceutical product in Country
- C. Examine decisions made about similar products in Country Y to propose the classification of the product.
- D. Submit the product for review as a pharmaceutical product in Country Y.
Answer: B
NEW QUESTION 65
......
Verified RAC-US dumps Q&As - 100% Pass from Exam4Labs: https://www.exam4labs.com/RAC-US-practice-torrent.html
Pass Exam With Full Sureness - RAC-US Dumps with 100 Questions: https://drive.google.com/open?id=1cSYbJf35ne-rC-7CVTAyoq7jI86QSoXH