QUESTION: 17

A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?

Specification
Formulation
Property
Justification

Answer(s): D

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In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation. However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

Discuss with the regulatory apriority and attempt to reach an acceptable solution.
Inform the internal departments to redesign the product to comply with this requirement.
Inform the regulatory authority that such a requirement is not applicable to the product.
Notify senior management that the product cannot be registered.

Answer(s): A

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QUESTION: 19

A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

Ask the trade association representative to provide an overview of the new product area to the marketing team.
Obtain competitor research and provide the information to the management team.
Obtain regulatory documents and history and provide the information to R&
Summarize regulatory documents and history and provide the information to the management team.

Answer(s): D

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QUESTION: 20

A global company has obtained a patent in a specific country for a newly marketed product. What would be the BEST advice In order to protect the patent in other countries?

Use the Madrid system.
Use the community patent system.
File patents of interest in target countries.
File design patents in target countries.

Answer(s): C

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QUESTION: 17

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QUESTION: 20