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NEW QUESTION 30
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. Consult with the legal department to discuss the best course of action.
- B. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
- C. Review the regulatory guidelines to determine how to proceed.
- D. Request a meeting with the regulatory authority to discuss the application.
Answer: D
NEW QUESTION 31
The requirements for document control are located in which of the following documents?
- A. ICH guidelines
- B. IEC 60601
- C. ISO 13485
- D. WHO guidelines
Answer: C
NEW QUESTION 32
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?
- A. Clinical investigations
- B. Literature search
- C. Adverse event reports
- D. Clinical experience
Answer: A
NEW QUESTION 33
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