Clinical Trials Failures – Homework Experts

After the end of day one, you will have been introduced to how a clinical trial can go terribly wrong based on the misinterpretation of safety data.
Design a safety package for a product with the following indication:

Find one example (not the one presented). Describe in one page (ONLY ONE Page) a very brief synopsis on what went wrong and how do you think that the design of the safety package could have been improved or if safety signals were missed and why.

This is due on Sept 23rd. Maximum 1-page, single space paper. Include references on a second page.

Google or Wikipedia are not considered legitimate references. You can use them to guide you in your searches. But published FDA guidelines and/or published literature must be used as the reference sources.