RAC-US Exam Dumps | A company is developing a new product for the global market. A new international guideline will recommend

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Question 30/36

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 since all relevant registration studies are almost completed.

B. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.

C. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.

D. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.

Question 30/36

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