Pass RAC-US Exam with Updated RAC-US Exam Dumps PDF 2023
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To be eligible to take the RAPS RAC-US certification exam, candidates must have a minimum of three years of regulatory experience. The exam is offered twice a year, in the spring and fall, and is administered at testing centers throughout the United States. Candidates who pass the exam earn the prestigious RAPS RAC-US certification, which is recognized by employers, clients, and stakeholders as a mark of excellence in the regulatory profession.
NEW QUESTION # 52
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?
- A. Early technical design and product release
- B. Concept development and early technical design
- C. Product release and validation
- D. Concept development and validation
Answer: B
NEW QUESTION # 53
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 demand a decision be made regarding the submission.
- B. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
- C. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
- D. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
Answer: C
NEW QUESTION # 54
A global company has obtained a patent in a specific country for a newly marketed product.
What would be the BEST advice In order to protect the patent in other countries?
- A. File design patents in target countries.
- B. Use the community patent system.
- C. Use the Madrid system.
- D. File patents of interest in target countries.
Answer: D
NEW QUESTION # 55
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Distributor
- B. Regulatory authority
- C. Consumer
- D. Manufacturer
Answer: D
NEW QUESTION # 56
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
- A. Strengthening a precaution to the product labeling
- B. Introducing a new analytical method
- C. Deleting a drug substance
- D. Deleting an ingredient of the drug product
Answer: A
NEW QUESTION # 57
Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?
- A. Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.
- B. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
- C. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
- D. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
Answer: C
NEW QUESTION # 58
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. Three years after the last clinical study site was supplied with investigational drugs
- B. For a minimum of 10 years after completion of the clinical study
- C. Until the product has been discontinued from marketing in all ICH regions
- D. For at least two years after the last approval of an application in an ICH region
Answer: D
NEW QUESTION # 59
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
- A. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation
- B. A brief summary of relevant physical, chemical, and pharmaceutical properties:
instructions for storage and handling of the dosage form: and a description of the formulation - C. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
- D. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
Answer: B
NEW QUESTION # 60
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. Analyze the impact of the international monograph change on the local pharmacopeia.
- B. Transfer the notice of the upcoming international monograph change to QA for further processing.
- C. Confirm that the international monograph change is not related to local pharmacopeia.
- D. Prepare the international monograph change submission first and then prepare the local change when required.
Answer: B
NEW QUESTION # 61
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. Prepare documents for the files.
- B. Communicate with the relevant internal departments.
- C. Contact the trade association for advice.
- D. Request a permanent waiver from the new regulation.
Answer: B
NEW QUESTION # 62
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. Quality
- B. Production
- C. Regulatory
- D. Analytical
Answer: A
NEW QUESTION # 63
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. The manufacturer's experience level with the type of IVD medical device is limited.
- C. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
- D. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
Answer: B
NEW QUESTION # 64
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. Enter into an agreement with Company Y to perform due diligence.
- B. Recruit a professional to gather confidential intelligence on Company Y.
- C. Perform a thorough library search to gather detailed information on Company Y.
- D. Request the needed information from the Board of Directors of Company Y.
Answer: A
NEW QUESTION # 65
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
- B. 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.
- C. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
- D. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
Answer: D
NEW QUESTION # 66
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?
- A. Government survey data indicate the product is superior.
- B. In vitro studies show the product to be superior.
- C. Results of a three-year, post-market patient survey indicate the product is superior.
- D. Results of adequate, well-controlled comparative clinical trial show the product is superior.
Answer: D
NEW QUESTION # 67
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