Fda during drug development and approval process

Reference no: EM133630419

Questions

1. What are some of the benefits of meeting with FDA during the drug development and approval process?

2. What are the two available FDA review timelines for new drugs and biologics, and what is the difference between them?

3. List the four expedited drug development and review programs. What do they share in common?

4. What is the role of an Advisory Committee in the drug approval process?

5. Apply the drug development and approval processes to a diabetes drug:

a. What specific health risk needs to be addressed when developing a diabetes drug?

b. How are sponsors supposed to mitigate this risk?

c. What is the primary efficacy endpoint a diabetes drug must demonstrate at the end of Phase 3 trials?

d. Why was this endpoint chosen?

e. Why is it unlikely for this fictional diabetes drug to be granted an expedited review by FDA?

Reference no: EM133630419

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