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NEW QUESTION 54
In which section of the ICH Common Technical Document will the overview of clinical data appear?

• A. Module 1
• B. Module 4
• C. Module 3
• D. Module 2

Answer: D

NEW QUESTION 55
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?

• A. 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
• B. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
• C. 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
• 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

Answer: C

NEW QUESTION 56
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. Prepare regulatory submissions that detail the medical device's change in materials.
• C. Write a memo to file since the change does not impact product safety and effectiveness.
• D. Review the content of change and supporting data for the equivalency with the current material.

Answer: D

NEW QUESTION 57
......