A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?

• A.Guidance documents for the device
• B.Determination of primary mode of action
• C.Determination of product design deliverables
• D.Approved indications of the drug

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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 the industry representative
• B.Before the enactment of the regulation, through formal comments gathering process
• C.Before the enactment of the regulation, through the industry representative
• D.After the enactment of the regulation, through a product-specific meeting

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

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Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?

• A.A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
• B.A brief summary of relevant physical, chemical, and pharmaceutical properties:
  instructions for storage and handling of the dosage form: and a description of the formulation
• C.A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
• D.A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation

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At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

• A.Quality improvement
• B.Clinical affairs
• C.Regulatory agency
• D.Quality assurance

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