Milestones in drug development and approval process

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Reference no: EM133645154

Questions

1. What are the milestones in the drug development and approval process?

2. Why is informed consent required for people participating in clinical studies?

3. What is the role of an IRB?

4. What types of nonclinical and clinical tests are completed before submission of a New Drug Application?

5. How are adverse events reported to FDA?

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

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

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

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

10. 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?

Reference no: EM133645154

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