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NEW QUESTION 30
What are the MOST important elements that global regulatory agencies want to know before approving a
new product for sale in their countries?

• A. Safety and failure risk
• B. Quality and failure risk
• C. Quality and effectiveness
• D. Safety and effectiveness

Answer: D

NEW QUESTION 31
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for
review and approval. The regulatory authority issues the company a written commitment that if the studies
are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and
safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre-specified
criteria, the company receives a letter from the regulatory authority stating that it no longer believes that
the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

• A. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the
  application.
• B. Request a meeting with the regulatory authority to discuss the application.
• C. Consult with the legal department to discuss the best course of action.
• D. Review the regulatory guidelines to determine how to proceed.

Answer: B

NEW QUESTION 32
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

• A. Phase III clinical trials
• B. Pre-clinical studies
• C. Phase I and II clinical trials
• D. Phase I clinical trials

Answer: A

NEW QUESTION 33
......

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