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Download Regulatory Affairs Certification (RAC) US Exam Dumps
NEW QUESTION 50
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
- A. Deleting a drug substance
- B. Strengthening a precaution to the product labeling
- C. Introducing a new analytical method
- D. Deleting an ingredient of the drug product
Answer: B
NEW QUESTION 51
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. Review the regulatory guidelines to determine how to proceed.
- 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. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
Answer: B
NEW QUESTION 52
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
- A. Class B
- B. Class A
- C. Class D
- D. Class C
Answer: D
NEW QUESTION 53
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