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NEW QUESTION: 1
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. Consult with the legal department to discuss the best course of action.
C. Request a meeting with the regulatory authority to discuss the application.
D. Review the regulatory guidelines to determine how to proceed.
Answer: C
NEW QUESTION: 2
Which of the following could be transmitted through kissing?
A. diabetes
B. lung cancer
C. brain tumor
D. Down's syndrome
E. flu
Answer: E
Explanation:
Explanation/Reference:
Explanation:
Only certain contagious diseases can be transmitted through kissing. Health problems associated with the other choices are not contagious. One can't get lung cancer, a brain tumor, diabetes, or Down's syndrome by kissing someone who has it.
NEW QUESTION: 3
A. Option D
B. Option B
C. Option A
D. Option C
E. Option E
Answer: D
Explanation:
* In most cases, ADDM output should be the first place that a DBA looks when notified of a performance problem.
* Performance degradation of the database occurs when your database was performing optimally in the past, such as 6 months ago, but has gradually degraded to a point where it becomes noticeable to the users. The Automatic Workload Repository (AWR) Compare Periods report enables you to compare database performance between two periods of time.
While an AWR report shows AWR data between two snapshots (or two points in time), the AWR Compare Periods report shows the difference between two periods (or two AWR reports with a total of four snapshots). Using the AWR Compare Periods report helps you to identify detailed performance attributes and configuration settings that differ between two time periods.
Reference: Resolving Performance Degradation Over Time