Use Real RAC-US - 100% Cover Real Exam Questions [Oct-2021]
Dumps Brief Outline Of The RAC-US Exam - TorrentValid
NEW QUESTION 53
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?
- A. Revision history
- B. Scope and level of detail
- C. Relevance to regulations
- D. Expiration date
Answer: C
NEW QUESTION 54
Company X and Company Y both have products for the treatment of rare genetic diseases.
Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?
- A. Perform a thorough library search to gather detailed information on Company Y.
- B. Request the needed information from the Board of Directors of Company Y.
- C. Recruit a professional to gather confidential intelligence on Company Y.
- D. Enter into an agreement with Company Y to perform due diligence.
Answer: D
NEW QUESTION 55
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
- A. Deleting an ingredient of the drug product
- B. Introducing a new analytical method
- C. Deleting a drug substance
- D. Strengthening a precaution to the product labeling
Answer: D
NEW QUESTION 56
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 manufacturer's experience level with the type of IVD medical device is limited.
- B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
- C. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
- D. The device incorporates well-established technology that is already present in the market.
Answer: A
NEW QUESTION 57
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. Compare the approved text with the product label
- D. Recommend an immediate product recall.
Answer: C
NEW QUESTION 58
Which of the following BEST describes the purpose of the ICH?
- A. To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions
- B. To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions
- C. To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions
- D. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
Answer: D
NEW QUESTION 59
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. Clinical trial data
- B. Safety issues
- C. Intellectual properly
- D. Marketing materials
Answer: B
NEW QUESTION 60
Which of the following is NOT required to be included in a marketing application?
- A. Evidence of fee payment
- B. Final printed label
- C. Administrative forms
- D. Quality, safety, and efficacy Information
Answer: A
NEW QUESTION 61
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. Educate patients and healthcare providers on how to use the product
- B. Delay product launch until required studies are completed.
- C. Promote off-label use to a carefully selected patient population.
- D. Label the product for use in appropriate populations.
Answer: C
NEW QUESTION 62
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. The minimum number of attendees necessary to address the issues
- C. All senior management from the main office
- D. As many as government attendees
Answer: B
NEW QUESTION 63
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. Production of Intermediate(s)
- C. Introduction of the API starting material
- D. Physical processing and packaging
Answer: D
NEW QUESTION 64
Which of the following is the PRIMARY purpose of an audit report?
- A. To carry out a complete review of product applications
- B. To document compliance history
- C. To define how to prepare new product submissions
- D. To train sales representatives
Answer: B
NEW QUESTION 65
A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?
- A. The ISO national member body
- B. The ISO Secretariat
- C. The country's regulatory authority
- D. The ISO technical committee in charge of the area
Answer: A
NEW QUESTION 66
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?
- A. The stability of the drug in all zone conditions
- B. Doha Declaration in the TRIPS Agreement
- C. The time frame in which the patent will expire
- D. International import and export regulations
Answer: A
NEW QUESTION 67
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
- A. Request a permanent waiver from the new regulation.
- B. Prepare documents for the files.
- C. Contact the trade association for advice.
- D. Communicate with the relevant internal departments.
Answer: D
NEW QUESTION 68
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
- A. Class D
- B. Class A
- C. Class B
- D. Class C
Answer: D
NEW QUESTION 69
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. Until the product has been discontinued from marketing in all ICH regions
- B. Three years after the last clinical study site was supplied with investigational drugs
- C. For a minimum of 10 years after completion of the clinical study
- D. For at least two years after the last approval of an application in an ICH region
Answer: D
NEW QUESTION 70
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 4
- B. Module 3
- C. Module 1
- D. Module 2
Answer: D
NEW QUESTION 71
After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?
- A. Verify the procedure in the regulation for the corrections.
- B. Contact the legal department and ask them how to proceed.
- C. Inform upper management immediately.
- D. Resubmit the entire package.
Answer: A
NEW QUESTION 72
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. Failure mode and effect analysis
- C. ISO 14971 risk analysis
- D. Fault tree analysis
Answer: C
NEW QUESTION 73
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?
- A. In vitro studies show the product to be superior.
- B. Government survey data indicate the product is superior.
- C. Results of adequate, well-controlled comparative clinical trial show the product is superior.
- D. Results of a three-year, post-market patient survey indicate the product is superior.
Answer: C
NEW QUESTION 74
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