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Download Regulatory Affairs Certification (RAC) US Exam Dumps
NEW QUESTION 42
A company’s product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?
- A. Delay product launch until required studies are completed.
- B. Label the product for use in appropriate populations.
- C. Educate patients and healthcare providers on how to use the product
- D. Promote off-label use to a carefully selected patient population.
Answer: D
NEW QUESTION 43
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?
- A. After the enactment of the regulation, through a product-specific meeting
- B. After the enactment of the regulation, through the industry representative
- C. Before the enactment of the regulation, through the industry representative
- D. Before the enactment of the regulation, through formal comments gathering process
Answer: D
NEW QUESTION 44
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?
- A. Physical processing and packaging
- B. Isolation and purification
- C. Introduction of the API starting material
- D. Production of Intermediate(s)
Answer: A
NEW QUESTION 45
Which of the following is NOT required to be included in a marketing application?
- A. Evidence of fee payment
- B. Final printed label
- C. Administrative forms
- D. Quality, safety, and efficacy Information
Answer: A
NEW QUESTION 46
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?
- A. Scope and level of detail
- B. Expiration date
- C. Revision history
- D. Relevance to regulations
Answer: D
NEW QUESTION 47
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