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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 either an identification study or a non-clinical qualification study.
• D. Perform both identification and non-clinical qualification studies concurrently.

A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?

• A. No action is needed in this situation.
• B. Review the content of change and supporting data for the equivalency with the current material.
• C. Prepare regulatory submissions that detail the medical device's change in materials.
• D. Write a memo to file since the change does not impact product safety and effectiveness.

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

• A. Contact the marketing department to recall the product.
• B. Request that doctors stop using the product for the off-label indication.
• C. Communicate with the sales department to stop using the promotional materials.
• D. Allow doctors to use the product for the off-label indication.

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 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
• D. 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

A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

• A. Inform the authority that the time is not suitable and request a new time
• B. Negotiate with colleagues and the authority to find a better time.
• C. Arrange for an inspection without all intended personnel.
• D. Insist that key personnel be available for the inspection.