Ace RAPS RAC-US Certification with Actual Questions Oct 26, 2022 Updated
2022 The Most Effective RAC-US with 100 Questions Answers
NEW QUESTION 30
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. Correct the label text.
- B. Delay the start of product production.
- C. Inform the regulatory authorities.
- D. Abort the product launch.
Answer: C
NEW QUESTION 31
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. Wait for the regulatory authority's final publication on its findings.
- B. Contact the regulatory authority to argue that its conclusions are wrong.
- C. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- D. Contact the regulatory authority to discuss its findings.
Answer: D
NEW QUESTION 32
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?
- A. Analytical
- B. Production
- C. Regulatory
- D. Quality
Answer: D
NEW QUESTION 33
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. Inform the local regulatory authority of the letter and discuss how to respond.
- B. Inform the legal department of the letter and discuss how to respond.
- C. Acknowledge receipt of the letter in a written response but do nothing further.
- D. Inform Company X that it has no right to send such a letter and do nothing further.
Answer: B
NEW QUESTION 34
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
- A. Document any failure to follow regulatory compliance processes in employee performance reviews.
- B. Train employees on all regulatory compliance processes using state-of-the-art systems.
- 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 35
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. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
- C. Ask that the regulatory authority provide the actual product subject to the complaint.
- D. Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release.
Answer: B
NEW QUESTION 36
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. Review the stability data for the changes.
- B. Assess the impact of the changes.
- C. Stop product manufacturing.
- D. Establish validation procedures.
Answer: C
NEW QUESTION 37
Which of the following claims would classify an apple as a drug?
- A. "It will whiten teeth."
- B. "It will make you look younger."
- C. "It will prevent colds."
- D. "It will satisfy hunger."
Answer: C
NEW QUESTION 38
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?
- A. The device incorporates well-established technology that is already present in the market.
- B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
- C. The manufacturer's experience level with the type of IVD medical device is limited.
- D. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
Answer: C
NEW QUESTION 39
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 for review as a pharmaceutical product in Country Y.
- B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
- C. Examine decisions made about similar products in Country Y to propose the classification of the product.
- D. Apply for review of the additional part of the product as a pharmaceutical product in Country
Answer: D
NEW QUESTION 40
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. Clinical experience
- B. Literature search
- C. Adverse event reports
- D. Clinical investigations
Answer: D
NEW QUESTION 41
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 1
- B. Module 2
- C. Module 4
- D. Module 3
Answer: B
NEW QUESTION 42
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
- A. Perform either an identification study or a non-clinical qualification study.
- B. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
- C. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
- D. Perform both identification and non-clinical qualification studies concurrently.
Answer: C
NEW QUESTION 43
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?
- A. Safety and effectiveness
- B. Safety and failure risk
- C. Quality and failure risk
- D. Quality and effectiveness
Answer: A
NEW QUESTION 44
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 local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
- C. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
- D. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
Answer: A
NEW QUESTION 45
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