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Course 3636
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Match the Medical Device Product classification with the descriptions and examples.
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The FDA is interested in meeting with companies during product development to ensure the company is on-track with the studies required to support the safety and efficacy of the product. What types of information can be discussed between the FDA and companies during the various formal meetings we discussed in class? (Select all that apply)
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Regarding Over the Counter Drugs (OTC), which of the following is/are true? (Select all that apply)
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Why is post-market surveillance necessary if clinical trials were conducted during product development? (select all that apply)
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Part of FDA approval of a generic drug is ensuring that the generic drug is equivalent to the innovator drug. Which of the following can be true for a generic drug, and still be considered equivalent to the innovator drug? (Select all that apply)
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Which of the following is/are true related to the development and approval of generic drugs (select all that apply):
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In order to see if employees are following procedures correctly, FDA will do the following while on inspection:
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Resolving complaints you receive from patients can be very difficult since:
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Which system is always inspected by the FDA:
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It is most important for senior leaders to focus on having a strong culture of quality so:
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