Differences between efficacy and effectiveness

Reference no: EM133199083

1. You will pretend you are one of the first hires in the regulatory office of a company that is about to manufacture its first medical product (for this exercise you get to decide if the product is a drug, biologic or device). Write a one to two-page essay on how you would go about developing a plan for the company that employs you to ensure they follow cGMP.

2. What are the differences between efficacy and effectiveness, according to the FDA?

3. What safety aspects of a biologic, drug, and medical device are taken into consideration during the approval process?

Reference no: EM133199083

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