Your research paper should include the following: 1. A complete time line for th
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Your research paper should include the following:
1. A complete time line for the drug’s development including approval dates for the various phases of FDA submission.
2. An overview of the sponsoring company and the drug’s treatment area.
3. The profitability of the drug including the length of time it has been on the market.
4. Did the recall violate specific parts of any applicable laws (e.g. FD&C Act, PHS Act, etc.)?
4. An overview of the recall issue including the amount of patients that were affected.
5. The response of the FDA, drug sponsor and general public to the recall.
6. What actions were taken by the FDA and the Drug sponsor in response the recall.
7. If the drug was reintroduced in the market, what are the changes to make this drug back into the market?