During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The
intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?

• A.Perform both identification and non-clinical qualification studies concurrently.
• B.Perform either an identification study or a non-clinical qualification study.
• C.Perform a non-clinical qualification study, wait until the result is available, and then consider performing
  an identification study.
• D.Perform an identification study, wait until the result is available, and then consider performing a
  non-clinical qualification study.

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After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level,
the medical device continues to have unacceptable risks. However, the development team wants to
continue development. Which is the BEST recommendation to make in this situation?

• A.Perform another risk-benefit analysis.
• B.Redesign the device.
• C.Discontinue the project.
• D.Add a warning in the IFU.

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Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A
regulatory authority requires that all labeling for Company Y's products be converted to Company X within
three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet
this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the
situation?

• A.Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority
  requirement and assign responsibilities.
• B.Submit as many labeling conversion applications as possible within the time frame and request an
  extension for the remaining ones.
• C.Request additional resources from senior management in order to complete the labeling conversion
  within the time frame given by the regulatory authority.
• D.Develop a plan of action with tasks, timelines, and responsibilities and request an extension period
  from the regulatory authority.

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A company is preparing the submission package for a drug to be registered in international markets.
When preparing the legal documentation, which document MUST comply with the WHO
recommendations?

• A.Certificate of Free Sale
• B.Certificate of GMP
• C.Certificate of Analysis for the finished product
• D.Certificate of Pharmaceutical Product

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

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