QUESTION: 37

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?

Before the enactment of the regulation, through the industry representative
Before the enactment of the regulation, through formal comments gathering process
After the enactment of the regulation, through the industry representative
After the enactment of the regulation, through a product-specific meeting

Answer(s): B

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QUESTION: 38

When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

Pre-clinical studies
Phase I clinical trials
Phase I and II clinical trials
Phase III clinical trials

Answer(s): D

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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?

Discuss with regulatory authorities to investigate how to have the off-label indication approved.
No action is required since it is an off-label use.
Advise the senior management to send a "Dear Dr." letter.
File a report to regulatory authorities and advise the marketing department to prevent future off-label use.

Answer(s): A

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QUESTION: 40

Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

Subject is hospitalized due to complications of the product administration.
Subject is hospitalized for the purpose of product administration.
Subject's hospitalization is due to an unscheduled hip operation.
Subject's hospitalization is prolonged during the clinical trial.

Answer(s): B,C

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QUESTION: 37

QUESTION: 38

QUESTION: 39

QUESTION: 40