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NEW QUESTION 33
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. Proposed product route and frequency of administration
• B. Proposed dose and volume of administration
• C. Immunochemical and functional tests
• D. Biological activity with species and/or tissue specificity

Answer: D

NEW QUESTION 34
A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

• A. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.
• B. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
• C. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
• D. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.

Answer: C

NEW QUESTION 35
A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

• A. Inform the production team.
• B. Recommend an immediate product recall.
• C. Notify the regulatory authority.
• D. Compare the approved text with the product label

Answer: D

NEW QUESTION 36
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