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NEW QUESTION 23
The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?

• A. Review alt distribution records and complaints reported in Country Y.
• B. Initiate a mandatory recall of the product in Country Y.
• C. Prepare the legal team in Country Y for possible litigations.
• D. Draft a formal letter to customers in Country Y about this recall.

Answer: A

NEW QUESTION 24
Which term does NOT describe the same concept as the others?

• A. Subsequent entry biologics
• B. Follow-on protein products
• C. Biosimilars
• D. Monoclonal antibody

Answer: D

NEW QUESTION 25
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

• A. Early technical design and product release
• B. Concept development and validation
• C. Concept development and early technical design
• D. Product release and validation

Answer: C

NEW QUESTION 26
A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of submission.
If there is no response after the deadline, what is the BEST approach?

• A. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
• B. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
• C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
• D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.

Answer: B

NEW QUESTION 27
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

• A. Biological activity with species and/or tissue specificity
• B. Proposed dose and volume of administration
• C. Proposed product route and frequency of administration
• D. Immunochemical and functional tests

Answer: A

NEW QUESTION 28
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