What is the Hatch-Waxman Act and why was it enacted?

FDA to initiate a Phase I trial?

What are the clinical phases of drug development? Provide a summary of the objectives of

each. Give an example of success at each stage.

Provide a detailed discussion of the approval process. Make sure to define and differentiate

between accelerated approval, fast track status and priority review. What role does the

advisory committee play?

What is the Hatch-Waxman Act and why was it enacted? What does it allow for? How is it

applicable to generics?

What are Orphan Drugs? Why have orphan drugs historically not been the focus of drug

development in early-stage biotechnology companies?

How does a start-up biotechnology company begin? Explain how management teams are

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