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NEW QUESTION # 81
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?
Answer: D
NEW QUESTION # 82
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?
Answer: A
NEW QUESTION # 83
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
Answer: B
NEW QUESTION # 84
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?
Answer: C
NEW QUESTION # 85
A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of submission.
If there is no response after the deadline, what is the BEST approach?
Answer: D
NEW QUESTION # 86
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Everything needs a right way. The good method can bring the result with half the effort, the same different exam also needs the good test method. Our RAC-US study questions in every year are summarized based on the test purpose, every answer is a template, there are subjective and objective exams of two parts, we have in the corresponding modules for different topic of deliberate practice. To this end, our RAC-US Training Materials in the qualification exam summarize some problem- solving skills, and induce some generic templates. The user can scout for answer and scout for score based on the answer templates we provide, so the universal template can save a lot of precious time for the user.
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