[Dec 05, 2021] Get New RAC-US Certification – Valid Exam Dumps Questions
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NEW QUESTION 39
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. Inform the internal departments to redesign the product to comply with this requirement.
- B. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
- C. Notify senior management that the product cannot be registered.
- D. Inform the regulatory authority that such a requirement is not applicable to the product.
Answer: B
NEW QUESTION 40
The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?
- A. Transfer the notice of the upcoming international monograph change to QA for further processing.
- B. Prepare the international monograph change submission first and then prepare the local change when required.
- C. Analyze the impact of the international monograph change on the local pharmacopeia.
- D. Confirm that the international monograph change is not related to local pharmacopeia.
Answer: A
NEW QUESTION 41
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. Marketing materials
- C. Clinical trial data
- D. Safety issues
Answer: D
NEW QUESTION 42
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. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.
- 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 actual product subject to the complaint.
- D. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
Answer: D
NEW QUESTION 43
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. Labeling
- B. Safety-related reporting
- C. Risk management process
- D. Regulatory application summary
Answer: A
NEW QUESTION 44
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. Discontinue the project.
- B. Redesign the device.
- C. Add a warning in the IFU.
- D. Perform another risk-benefit analysis.
Answer: B
NEW QUESTION 45
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?
- A. "Product X is effective in all patients with arthritis."
- B. "Product X is safe for arthritis and without side effects."
- C. "Product X is effective for the treatment of arthritis."
- D. "Product X is a guaranteed cure for arthritis."
Answer: C
NEW QUESTION 46
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject's hospitalization is due to an unscheduled hip operation.
- B. Subject's hospitalization is prolonged during the clinical trial.
- C. Subject is hospitalized due to complications of the product administration.
- D. Subject is hospitalized for the purpose of product administration.
Answer: D
NEW QUESTION 47
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. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
- D. Review the regulatory guidelines to determine how to proceed.
Answer: A
NEW QUESTION 48
According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: B
NEW QUESTION 49
The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
- A. 200 patients for nine months
- B. 3.000 total patient exposures
- C. 100 patients for 12 months
- D. 500 patients for three months
Answer: C
NEW QUESTION 50
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
- A. Train all new employees on regulatory compliance processes and assign a mentor to them.
- B. Develop documented procedures for regulatory compliance processes and train personnel.
- C. Train employees on all regulatory compliance processes using state-of-the-art systems.
- D. Document any failure to follow regulatory compliance processes in employee performance reviews.
Answer: B
NEW QUESTION 51
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Import license
- B. Export license
- C. Site license
- D. Product license
Answer: C
NEW QUESTION 52
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. Prepare the legal team in Country Y for possible litigations.
- B. Initiate a mandatory recall of the product in Country Y.
- C. Review alt distribution records and complaints reported in Country Y.
- D. Draft a formal letter to customers in Country Y about this recall.
Answer: C
NEW QUESTION 53
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
- A. Risk analysis
- B. Instructions for use
- C. Product literature
- D. Essential principles
Answer: A
NEW QUESTION 54
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. As many as required by international standards
- B. All senior management from the main office
- C. As many as government attendees
- D. The minimum number of attendees necessary to address the issues
Answer: D
NEW QUESTION 55
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 information to provide at this time, but we can 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."
Answer: B
NEW QUESTION 56
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. Document and perform audits.
- B. Request documentation from the sub-contractor.
- C. Request an inspection from a regulatory authority.
- D. Ask the vendor to take responsibility.
Answer: A
NEW QUESTION 57
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
- A. Formulation
- B. Specification
- C. Property
- D. Justification
Answer: D
NEW QUESTION 58
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
- A. Introducing a new analytical method
- B. Deleting an ingredient of the drug product
- C. Strengthening a precaution to the product labeling
- D. Deleting a drug substance
Answer: C
NEW QUESTION 59
Which of the following is NOT required to be included in a marketing application?
- A. Evidence of fee payment
- B. Administrative forms
- C. Quality, safety, and efficacy Information
- D. Final printed label
Answer: A
NEW QUESTION 60
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. Placebo-controlled
- B. Cross-over
- C. Active-controlled
- D. Dose-ranging
Answer: B
NEW QUESTION 61
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?
- A. Production of Intermediate(s)
- B. Isolation and purification
- C. Physical processing and packaging
- D. Introduction of the API starting material
Answer: C
NEW QUESTION 62
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