[2021] New RAC-GS exam dumps Use Updated RAPS Exam
Verified RAC-GS Dumps Q&As - RAC-GS Test Engine with Correct Answers
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. "We have no additional information to provide at this time because we have already provided
everything needed to support our product's approval." - B. "Given the advisory committee's unanimous decision, we know that the product will not be approved,
and additional data will not make any difference." - 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, but we can perform an additional analysis for
a specific safety concern, if necessary."
Answer: D
NEW QUESTION 56
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. Literature search
- C. Clinical experience
- D. Clinical investigations
Answer: D
NEW QUESTION 57
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Pre-clinical studies
- B. Phase I clinical trials
- C. Phase I and II clinical trials
- D. Phase III clinical trials
Answer: D
NEW QUESTION 58
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 59
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 60
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices
as long as the marketing application is under review by the regulatory authority. - B. Although the regulatory authority reviews and approves drugs for specific indications, the approval
does not limit the use of those drugs in clinical practice. - C. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby
increasing access to much needed drugs and devices. - D. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the
manufacturer's promotion for such use.
Answer: B
NEW QUESTION 61
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 62
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. Prepare the international monograph change submission first and then prepare the local change when
required. - B. Transfer the notice of the upcoming international monograph change to QA for further processing.
- 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: B
NEW QUESTION 63
A clinical study of a drug is completed to support a marketing approval application. According to ICH, how
long should a sponsor retain the clinical study essential documents?
- A. For at least two years after the last approval of an application in an ICH region
- B. Three years after the last clinical study site was supplied with investigational drugs
- C. Until the product has been discontinued from marketing in all ICH regions
- D. For a minimum of 10 years after completion of the clinical study
Answer: A
NEW QUESTION 64
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. Allow the auditor access to the room and records due to the current audit.
- C. Deny the auditor access to the room and records due to confidentiality concerns.
- D. Deny the auditor access to the room and retrieve only the requested records.
Answer: A
NEW QUESTION 65
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a
reimbursement agency?
- A. "Is the product an established gold standard?"
- B. "Is the product profitable for the manufacturer?"
- C. "Is the product better than currently available alternatives?"
- D. "Has the product been approved for mor&4nan 10 years?"
Answer: C
NEW QUESTION 66
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. Inform the regulatory authorities.
- B. Delay the start of product production.
- C. Correct the label text.
- D. Abort the product launch.
Answer: A
NEW QUESTION 67
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 68
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 69
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. Label the product for use in appropriate populations.
- B. Promote off-label use to a carefully selected patient population.
- C. Delay product launch until required studies are completed.
- D. Educate patients and healthcare providers on how to use the product
Answer: B
NEW QUESTION 70
Which of the following is the PRIMARY purpose of an audit report?
- A. To document compliance history
- B. To define how to prepare new product submissions
- C. To train sales representatives
- D. To carry out a complete review of product applications
Answer: A
NEW QUESTION 71
Why is it necessary to run supplemental safety pharmacology studies?
- A. To substitute the utilization of GLP
- B. To comply with regulatory authority requirements related to clinical studies
- C. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
- D. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
Answer: C
NEW QUESTION 72
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. Assess the impact of the changes.
- B. Stop product manufacturing.
- C. Establish validation procedures.
- D. Review the stability data for the changes.
Answer: B
NEW QUESTION 73
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 74
A company is developing a device-drug combination product. Which of the following should be evaluated
FIRST in order to determine the applicable guidance documents?
- A. Guidance documents for the device
- B. Determination of product design deliverables
- C. Approved indications of the drug
- D. Determination of primary mode of action
Answer: B
NEW QUESTION 75
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 76
Which of the following is MOST appropriate for the purpose of lot release of biologics?
- A. Quality verification
- B. Inventory control
- C. Efficacy confirmation
- D. Safety assurance
Answer: A
NEW QUESTION 77
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 78
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