Describe some characteristics of the research and development of new medical products. 1. Describe some characteristics of the research and development of new medical products.

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Describe some characteristics of the research and development of new medical products.
1. Describe some characteristics of the research and development of new medical products.

2. Compare the requirements for new medical products to obtain FDA approval to that of generic versions. Why do they differ?

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3. May clinical trial research ever be conducted without obtaining informed consent?

4. What does the informed consent process provide to participants? May informed consent be obtained from children?

5. What did a government report, authored in 2001, conclude about Pfizer’s clinical trial of the drug Trovan in Nigeria? What happened to the report? What subsequently happened to Pfizer?

Explanation & Answer

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