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Download Regulatory Affairs Certification (RAC) US Exam Dumps
NEW QUESTION 32
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?
- A. Arrange for an inspection without all intended personnel.
- B. Inform the authority that the time is not suitable and request a new time
- C. Negotiate with colleagues and the authority to find a better time.
- D. Insist that key personnel be available for the inspection.
Answer: C
NEW QUESTION 33
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. Wait for the regulatory authority's final publication on its findings.
- B. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- C. Contact the regulatory authority to argue that its conclusions are wrong.
- D. Contact the regulatory authority to discuss its findings.
Answer: D
NEW QUESTION 34
You discover that your company's top selling product in the last two years has been used off-label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?
- A. No action is required since it is an off-label use.
- B. Advise the senior management to send a "Dear Dr." letter.
- C. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
- D. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
Answer: D
NEW QUESTION 35
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Distributor
- B. Consumer
- C. Regulatory authority
- D. Manufacturer
Answer: D
NEW QUESTION 36
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