FDA Withdrawal of Pemoline Article

FDA Withdrawal of Pemoline Article essay assignment

Please review the attached paper and article that as selected. This assignment is a peer review. The following must be included in the paper:

Summarize the article and discuss why the drug was pulled from the market.
Review clinical trial data and information and identify how the data was collected and managed.
Was there a Data Monitoring Committee (DMC)? Summarize the DMC safety findings. If there was no DMC, why?
Discuss, based on information collected, whether the events that occurred after the drug was marketed that required pulling the drug, could have been determined during the clinical trial phases.
What could (if anything) the sponsor have done differently?

Get solution to your nursing paper : FDA Withdrawal of Pemoline Article

There needs to be a thorough review of this paper and comments/feedback provided. Please ensure there is additional information and feedbakc that is provided for each topic listed in the paper

Original Assignment:

review and discuss an article related to an approved drug that was pulled from the market for safety concerns. You will be partnered with a colleague from this course for review of the paper. Each student will complete their project and submit it for review by the instructor. In addition, you will share your paper with your student partner who will do a peer review of your paper and comment on your paper. You will be assigned a student peer. Once you have completed your peer review return it to your partner as well as to the instructor.

The FDA reviews the data collected in clinical trials to determine whether a drug or device is safe and effective for marketing approval. Complete and accurate data is essential to ensuring consumer safety once a drug or device has been approved for market. Even after thorough review of the data collected, drugs are occasionally approved for market that end up being pulled because of significant adverse events and death. For this assignment find an article on a drug that was approved by the FDA for market and then pulled due to safety concerns (AEs, SAEs, deaths). Go back and review data and information you can find on the clinical trials conducted for the drug. Look at the data that was collected, AEs and SAEs, study findings, reports, etc. In a 4 – 6 page, APA formatted paper summarize and discuss the article including the following information:

Summarize the article and discuss why the drug was pulled from the market.
Review clinical trial data and information and identify how the data was collected and managed.
Was there a Data Monitoring Committee (DMC)? Summarize the DMC safety findings. If there was no DMC, why?
Discuss, based on information collected, whether the events that occurred after the drug was marketed that required pulling the drug, could have been determined during the clinical trial phases.
What could (if anything) the sponsor have done differently?

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FDA Withdrawal of Pemoline Article