RAC-US認證題庫 & RAC-US软件版 - RAC-US新版題庫上線
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下載Regulatory Affairs Certification (RAC) US考試題庫
NEW QUESTION 31
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
- A. Notify senior management that the product cannot be registered.
- B. Inform the regulatory authority that such a requirement is not applicable to the product.
- C. Inform the internal departments to redesign the product to comply with this requirement.
- D. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
Answer: D
NEW QUESTION 32
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. Draft a formal letter to customers in Country Y about this recall.
- B. Initiate a mandatory recall of the product in Country Y.
- C. Review alt distribution records and complaints reported in Country Y.
- D. Prepare the legal team in Country Y for possible litigations.
Answer: C
NEW QUESTION 33
Why is it necessary to run supplemental safety pharmacology studies?
- A. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
- B. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
- C. To comply with regulatory authority requirements related to clinical studies
- D. To substitute the utilization of GLP
Answer: B
NEW QUESTION 34
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