[2021] Pass RAPS RAC-US Premium Files Test Engine pdf - Free Dumps Collection
New 2021 Realistic RAC-US Dumps Test Engine Exam Questions in here
NEW QUESTION 13
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?
- A. "Is the product an established gold standard?"
- B. "Is the product profitable for the manufacturer?"
- C. "Is the product better than currently available alternatives?"
- D. "Has the product been approved for mor&4nan 10 years?"
Answer: C
NEW QUESTION 14
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?
- A. Guidance documents for the device
- B. Determination of product design deliverables
- C. Approved indications of the drug
- D. Determination of primary mode of action
Answer: B
NEW QUESTION 15
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?
- A. Apply for review of the additional part of the product as a pharmaceutical product in Country
- B. Submit the product for review as a pharmaceutical product in Country Y.
- C. Examine decisions made about similar products in Country Y to propose the classification of the product.
- D. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
Answer: A
NEW QUESTION 16
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. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
- C. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
- D. 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.
Answer: C
NEW QUESTION 17
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 18
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?
- A. Risk analysis
- B. Risk estimation
- C. Risk control
- D. Risk management
Answer: A
NEW QUESTION 19
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Pre-clinical studies
- B. Phase I clinical trials
- C. Phase I and II clinical trials
- D. Phase III clinical trials
Answer: D
NEW QUESTION 20
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 21
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 22
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 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 23
Which term does NOT describe the same concept as the others?
- A. Monoclonal antibody
- B. Follow-on protein products
- C. Biosimilars
- D. Subsequent entry biologics
Answer: A
NEW QUESTION 24
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 25
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. Concept development and early technical design
- B. Early technical design and product release
- C. Product release and validation
- D. Concept development and validation
Answer: A
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
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
- A. Document and perform audits.
- B. Request documentation from the sub-contractor.
- C. Request an inspection from a regulatory authority.
- D. Ask the vendor to take responsibility.
Answer: A
NEW QUESTION 28
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
- A. After the enactment of the regulation, through the industry representative
- B. Before the enactment of the regulation, through the industry representative
- C. After the enactment of the regulation, through a product-specific meeting
- D. Before the enactment of the regulation, through formal comments gathering process
Answer: D
NEW QUESTION 29
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
- A. 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
- B. 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
- C. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
- D. 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
Answer: D
NEW QUESTION 30
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
- A. Train all new employees on regulatory compliance processes and assign a mentor to them.
- B. Develop documented procedures for regulatory compliance processes and train personnel.
- C. Train employees on all regulatory compliance processes using state-of-the-art systems.
- D. Document any failure to follow regulatory compliance processes in employee performance reviews.
Answer: B
NEW QUESTION 31
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 2
- B. Module 1
- C. Module 4
- D. Module 3
Answer: A
NEW QUESTION 32
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?
- A. Increase the frequency of monitoring visits.
- B. Terminate the PI and inform the regulatory authorities.
- C. Inform the institution that granted a medical license to the Pi.
- D. Send a letter of complaint to the Ethics Committee that approved the site.
Answer: B
NEW QUESTION 33
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. Transfer the notice of the upcoming international monograph change to QA for further processing.
- B. Prepare the international monograph change submission first and then prepare the local change when required.
- C. Analyze the impact of the international monograph change on the local pharmacopeia.
- D. Confirm that the international monograph change is not related to local pharmacopeia.
Answer: A
NEW QUESTION 34
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