Released RAPS RAC-US Updated Questions PDF
RAC-US Dumps and Practice Test (100 Exam Questions)
NEW QUESTION 32
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?
- A. Develop a generic version of the drug.
- B. Develop a better brand-name drug in the same class.
- C. Explore litigation strategy for patent infringements on the drug.
- D. Conduct a Phase III study for a new unrelated indication of the drug.
Answer: A
NEW QUESTION 33
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. Information deemed appropriate by the regulatory authority
- C. The process information and analytical result of Company Y API
- D. The process information and analytical result of Company X API
Answer: A
NEW QUESTION 34
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject's hospitalization is due to an unscheduled hip operation.
- B. Subject's hospitalization is prolonged during the clinical trial.
- C. Subject is hospitalized due to complications of the product administration.
- D. Subject is hospitalized for the purpose of product administration.
Answer: D
NEW QUESTION 35
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 either an identification study or a non-clinical qualification study.
- D. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
Answer: B
NEW QUESTION 36
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 37
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 38
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. ISO 14971 risk analysis
- B. Failure mode and effect analysis
- C. Hazard and operability study
- D. Fault tree analysis
Answer: A
NEW QUESTION 39
According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: B
NEW QUESTION 40
A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?
- A. Frequent communication
- B. Follow-up meeting after submission
- C. Documented agreement
- D. Early collaboration
Answer: A
NEW QUESTION 41
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?
- A. Adverse event caused by patient conditions
- B. Deficiency of a device found by the user prior to patient use
- C. Malfunction occurring before the end of service life of the medical device
- D. Malfunction protection operated correctly
Answer: A
NEW QUESTION 42
According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: A
NEW QUESTION 43
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. Recruit a professional to gather confidential intelligence on Company Y.
- B. Request the needed information from the Board of Directors of Company Y.
- C. Perform a thorough library search to gather detailed information on Company Y.
- D. Enter into an agreement with Company Y to perform due diligence.
Answer: D
NEW QUESTION 44
During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?
- A. Request that doctors stop using the product for the off-label indication.
- B. Communicate with the sales department to stop using the promotional materials.
- C. Allow doctors to use the product for the off-label indication.
- D. Contact the marketing department to recall the product.
Answer: B
NEW QUESTION 45
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 46
Which of the following BEST describes the purpose of the ICH?
- A. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
- B. To protect and promote public health through the evaluation and supervision of 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 lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions
Answer: A
NEW QUESTION 47
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