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NEW QUESTION 26
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. Approved indications of the drug
- B. Determination of product design deliverables
- C. Guidance documents for the device
- D. Determination of primary mode of action
Answer: B
NEW QUESTION 27
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. Request that doctors stop using the product for the off-label indication.
- B. Communicate with the sales department to stop using the promotional materials.
- C. Contact the marketing department to recall the product.
- D. Allow doctors to use the product for the off-label indication.
Answer: B
NEW QUESTION 28
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
- A. Plasma pooling
- B. Product distribution
- C. Individual plasma donation
- D. Plasma fractionation
Answer: B
NEW QUESTION 29
The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?
- A. The process information and the comparative analytical result of APIs from both companies
- B. The process information and analytical result of Company Y API
- C. The process information and analytical result of Company X API
- D. Information deemed appropriate by the regulatory authority
Answer: A
NEW QUESTION 30
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