US RAC Review Questions RAPS Modules Questions and Answers | Latest Update | 2024/2025 | Already Passed
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US RAC
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US RAC
US RAC Review Questions RAPS
Modules Questions and Answers | Latest
Update | 2024/2025 | Already Passed
What is the main purpose of the Risk Evaluation and Mitigation Strategies (REMS)?
A) To ensure that the benefits of a drug outweigh its risks
B) To promote sales strategies
C) To conduct ...
US RAC Review Questions RAPS
Modules Questions and Answers | Latest
Update | 2024/2025 | Already Passed
What is the main purpose of the Risk Evaluation and Mitigation Strategies (REMS)?
✔✔A) To ensure that the benefits of a drug outweigh its risks
B) To promote sales strategies
C) To conduct patient surveys
D) To facilitate drug manufacturing
Which regulatory submission is required for a device that is significantly different from existing
products?
✔✔A) Premarket Approval (PMA)
B) 510(k) notification
C) Investigational Device Exemption (IDE)
D) Abbreviated NDA
What does the term "clinical hold" mean in the context of clinical trials?
✔✔A) A temporary halt to a clinical study due to safety concerns
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,B) A final approval of the study
C) The completion of all trial phases
D) A marketing strategy to hold product interest
In regulatory affairs, what is meant by the term "labeling"?
✔✔A) Information provided with a product about its use and risks
B) The branding of a product
C) The design of the product packaging
D) The advertising strategy
What is the primary function of the Institutional Review Board (IRB)?
A) To approve marketing materials
B) To supervise clinical trial funding
✔✔C) To protect the rights and welfare of human research subjects
D) To manage post-market surveillance
Which regulatory framework applies to combination products that include both drug and device
components?
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,✔✔A) The combination product regulations
B) The drug approval process only
C) The device approval process only
D) The clinical trial regulations only
What is the main focus of post-market studies?
✔✔A) To monitor long-term safety and effectiveness of products
B) To conduct initial marketing research
C) To design new clinical trials
D) To reduce production costs
What does the term "fast track" designation mean?
A) An expedited marketing strategy
✔✔B) A process designed to facilitate the development and expedite the review of drugs that
treat serious conditions
C) A special promotion for certain drugs
D) A fast-track approval for clinical trials only
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, Which of the following is a common reason for a drug application rejection by the FDA?
A) High sales projections
✔✔B) Insufficient evidence of safety and efficacy
C) Strong market competition
D) Incomplete packaging
What is the significance of the "safety data sheet" (SDS) in regulatory compliance?
✔✔A) It provides information on the safe use and handling of hazardous substances
B) It details the marketing strategy for the product
C) It serves as a guide for manufacturing processes
D) It is used for financial reporting
What does "substantial equivalence" refer to in the context of medical devices?
✔✔A) A determination that a new device is as safe and effective as a legally marketed device
B) The approval of a new drug
C) The process of conducting clinical trials
D) The marketing authorization for a device
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