QUESTION: 13

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?

The process information and analytical result of Company X API
The process information and analytical result of Company Y API
The process information and the comparative analytical result of APIs from both companies
Information deemed appropriate by the regulatory authority

Answer(s): C

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QUESTION: 14

Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

Fishbone analysis
Failure modes, effects, and criticality analysis
Fault tree analysis
Quality by design analysis

Answer(s): B

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QUESTION: 15

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?

Label the product for use in appropriate populations.
Educate patients and healthcare providers on how to use the product
Delay product launch until required studies are completed.
Promote off-label use to a carefully selected patient population.

Answer(s): D

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QUESTION: 16

Which of the following statements regarding the off-label use of drugs is CORRECT?

Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.

Answer(s): A

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QUESTION: 16