Before a new drug approved by FDA, it requires the applicants seeking the approval to provide the FDA with the results of clinical trials on 100 patients (Phase IV clinical trial) and report the serious complications. Last year, 25 applications for new drug approval were filed with FDA seeking the approval. Exhibit "B" provides the data provided to FDA by applicants.

9. Should any of the applications be rejected by FDA?

10. Does the requirements for using an appropriate SPC chart was satisfied here? Why?

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