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最新的 RAC Regulatory Affairs Certification RAC-US 免費考試真題:

1. During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate
FIRST step for the company to take?

A) Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
B) Contact the regulatory authority to discuss its findings.
C) Contact the regulatory authority to argue that its conclusions are wrong.
D) Wait for the regulatory authority's final publication on its findings.

2. Which of the following is MOST appropriate for the purpose of lot release of biologics?

A) Safety assurance
B) Efficacy confirmation
C) Quality verification
D) Inventory control

3. 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

4. The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

A) 500 patients for three months
B) 3.000 total patient exposures
C) 100 patients for 12 months
D) 200 patients for nine months

5. 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) Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
B) The manufacturer's experience level with the type of IVD medical device is limited.
C) The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
D) The device incorporates well-established technology that is already present in the market.

問題與答案：