View RAC-US Exam Question Dumps With Latest Demo [May 21, 2023]
Free RAC-US Test Questions Real Practice Test Questions
The Regulatory Affairs Certification (RAC) US Certification Exam is a professional certification program that is recognized in the regulatory affairs industry. The exam is designed to test the knowledge and skills of regulatory affairs professionals in the United States. The RAC-US exam is administered by the Regulatory Affairs Professionals Society (RAPS), a global organization that represents the interests of regulatory professionals worldwide.
The RAPS RAC-US certification exam is designed for regulatory professionals at all levels, from entry-level to senior executives. The exam is intended to provide a benchmark for regulatory professionals and to demonstrate their knowledge and expertise to employers, clients, and stakeholders. The certification is also an excellent way for regulatory professionals to enhance their careers and to open up new opportunities in the field.
NEW QUESTION # 43
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Distributor
- B. Consumer
- C. Regulatory authority
- D. Manufacturer
Answer: D
NEW QUESTION # 44
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. Production
- B. Quality
- C. Analytical
- D. Regulatory
Answer: B
NEW QUESTION # 45
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. Consult with the legal department to discuss the best course of action.
- B. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
- C. Review the regulatory guidelines to determine how to proceed.
- D. Request a meeting with the regulatory authority to discuss the application.
Answer: D
NEW QUESTION # 46
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. ISO 14971 risk analysis
- C. Fault tree analysis
- D. Failure mode and effect analysis
Answer: B
NEW QUESTION # 47
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
- A. Develop documented procedures for regulatory compliance processes and train personnel.
- B. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Train employees on all regulatory compliance processes using state-of-the-art systems.
- D. Train all new employees on regulatory compliance processes and assign a mentor to them.
Answer: A
NEW QUESTION # 48
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. Review alt distribution records and complaints reported in Country Y.
- B. Initiate a mandatory recall of the product in Country Y.
- C. Prepare the legal team in Country Y for possible litigations.
- D. Draft a formal letter to customers in Country Y about this recall.
Answer: A
NEW QUESTION # 49
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase III clinical trials
- B. Phase I clinical trials
- C. Phase I and II clinical trials
- D. Pre-clinical studies
Answer: A
NEW QUESTION # 50
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?
- A. Proposed product route and frequency of administration
- B. Immunochemical and functional tests
- C. Proposed dose and volume of administration
- D. Biological activity with species and/or tissue specificity
Answer: D
NEW QUESTION # 51
The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?
- A. The process information and the comparative analytical result of APIs from both companies
- B. The process information and analytical result of Company X API
- C. Information deemed appropriate by the regulatory authority
- D. The process information and analytical result of Company Y API
Answer: A
NEW QUESTION # 52
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. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
- B. Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.
- C. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
- D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
Answer: C
NEW QUESTION # 53
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject is hospitalized for the purpose of product administration.
- B. Subject is hospitalized due to complications of the product administration.
- C. Subject's hospitalization is prolonged during the clinical trial.
- D. Subject's hospitalization is due to an unscheduled hip operation.
Answer: A
NEW QUESTION # 54
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 both identification and non-clinical qualification studies concurrently.
- B. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
- C. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
- D. Perform either an identification study or a non-clinical qualification study.
Answer: B
NEW QUESTION # 55
The requirements for document control are located in which of the following documents?
- A. WHO guidelines
- B. ISO 13485
- C. IEC 60601
- D. ICH guidelines
Answer: B
NEW QUESTION # 56
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. Active-controlled
- B. Cross-over
- C. Dose-ranging
- D. Placebo-controlled
Answer: B
NEW QUESTION # 57
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. Confirm that the international monograph change is not related to local pharmacopeia.
- C. Transfer the notice of the upcoming international monograph change to QA for further processing.
- D. Prepare the international monograph change submission first and then prepare the local change when required.
Answer: C
NEW QUESTION # 58
A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?
- A. Initiate testing immediately to ensure compliance.
- B. Contact the regulatory authority that issued this request and discuss the requirement.
- C. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
- D. Consult with colleagues about the request.
Answer: B
NEW QUESTION # 59
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?
- A. Deficiency of a device found by the user prior to patient use
- B. Adverse event caused by patient conditions
- C. Malfunction protection operated correctly
- D. Malfunction occurring before the end of service life of the medical device
Answer: B
NEW QUESTION # 60
A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?
- A. Obtain regulatory documents and history and provide the information to R&D.
- B. Obtain competitor research and provide the information to the management team.
- C. Summarize regulatory documents and history and provide the information to the management team.
- D. Ask the trade association representative to provide an overview of the new product area to the marketing team.
Answer: C
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. Final printed label
- D. Quality, safety, and efficacy Information
Answer: A
NEW QUESTION # 62
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 # 63
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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.
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