Pass Your Exam With 100% Verified RAC-US Exam Questions
RAC-US Dumps PDF - RAC-US Real Exam Questions Answers
NEW QUESTION 24
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
- A. Plasma pooling
- B. Plasma fractionation
- C. Individual plasma donation
- D. Product distribution
Answer: D
NEW QUESTION 25
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. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
- B. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."
- 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 because we have already provided everything needed to support our product's approval."
Answer: B
NEW QUESTION 26
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?
- A. No action is needed in this situation.
- B. Write a memo to file since the change does not impact product safety and effectiveness.
- C. Review the content of change and supporting data for the equivalency with the current material.
- D. Prepare regulatory submissions that detail the medical device's change in materials.
Answer: C
NEW QUESTION 27
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 28
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Import license
- B. Export license
- C. Site license
- D. Product license
Answer: C
NEW QUESTION 29
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?
- A. Expiration date
- B. Scope and level of detail
- C. Revision history
- D. Relevance to regulations
Answer: D
NEW QUESTION 30
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 31
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?
- A. "Product X is effective in all patients with arthritis."
- B. "Product X is safe for arthritis and without side effects."
- C. "Product X is effective for the treatment of arthritis."
- D. "Product X is a guaranteed cure for arthritis."
Answer: C
NEW QUESTION 32
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 33
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?
- A. Production of Intermediate(s)
- B. Isolation and purification
- C. Physical processing and packaging
- D. Introduction of the API starting material
Answer: C
NEW QUESTION 34
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 technical committee in charge of the area
- C. The ISO Secretariat
- D. The country's regulatory authority
Answer: A
NEW QUESTION 35
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 36
After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?
- A. Discontinue the project.
- B. Redesign the device.
- C. Add a warning in the IFU.
- D. Perform another risk-benefit analysis.
Answer: B
NEW QUESTION 37
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?
- A. Service operation procedures
- B. Local reimbursement requirements
- C. Training program for sales people
- D. Written procedure for product traceability
Answer: C
NEW QUESTION 38
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. 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 manufacturer's experience level with the type of IVD medical device is limited.
Answer: D
NEW QUESTION 39
According to ICH, which of the following components of study information is NOT required in a clinical study report?
- A. Randomization scheme and codes
- B. Protocol and protocol amendments
- C. Detailed CV of all investigators
- D. List of lECs or lRBs
Answer: C
NEW QUESTION 40
......
RAC-US Dumps 100 Pass Guarantee With Latest Demo: https://www.topexamcollection.com/RAC-US-vce-collection.html
Prepare RAC-US Question Answers Free Update With 100% Exam Passing Guarantee [2021]: https://drive.google.com/open?id=1z65DYV4PFESGKzfkA8W_U_sZnLpvPED6
