QUESTION: 17

After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

Resubmit the entire package.
Inform upper management immediately.
Contact the legal department and ask them how to proceed.
Verify the procedure in the regulation for the corrections.

Answer(s): D

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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?

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

Answer(s): A,D

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QUESTION: 19

Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?