Discuss about compassionate use of investigational products

Reference no: EM133414446

Assignment:

We have talked about Expanded Access and Compassionate Use of investigational products. In addition to this type of limited use of investigational drugs before full FDA approval, there is Emergency Authorization. In the supplemental materials, you will find a October 2020 FDA Guidance on the Emergency Authorization of a COVID 19 vaccine. Please review the guidance and discuss it on the Discussion Board by responding to one of these Questions/Topics:

1. Briefly summarize how such an authorization can be obtained.

2. Contrast the differences between obtaining an Emergency Authorization and obtaining approval to use an investigational drug through expanded access or compassionate use.

3. Do you think the risks of making investigational products available through Compassionate Use or Emergency Authorization is ethical in terms of what you have learned in this class and what are the risks and benefits to patients?

Reference no: EM133414446

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