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NEW QUESTION 53
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

• A. Systematic procedure to review experiences with the products in use
• B. Vigilance procedure to notify the regulatory authorities about serious incidents
• C. Systematic procedure to review published scientific journals
• D. Vigilance procedure to ensure the full traceability of the products

Answer: D

NEW QUESTION 54
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

• A. Regulatory
• B. Analytical
• C. Production
• D. Quality

Answer: D

NEW QUESTION 55
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

• A. Results of a three-year, post-market patient survey indicate the product is superior.
• B. In vitro studies show the product to be superior.
• C. Government survey data indicate the product is superior.
• D. Results of adequate, well-controlled comparative clinical trial show the product is superior.

Answer: D

NEW QUESTION 56
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