RAPS Regulatory Affairs Certification (RAC) US - RAC-US FREE EXAM DUMPS QUESTIONS & ANSWERS
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?
Correct Answer: A
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Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
Correct Answer: A
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Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?
Correct Answer: D
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A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?
Which aspect of the SOP Is MOST important to consider?
Correct Answer: A
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After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?
Correct Answer: C
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The requirements for document control are located in which of the following documents?
Correct Answer: C
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The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?
Correct Answer: D
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An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?
Correct Answer: A
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During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
What should be done in response to identifying the impurity?
Correct Answer: D
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In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?
Correct Answer: B
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