What are the clinical phases of drug development?

Explain the objectives of the preclinical phase of development. How does a company decide to

go forward with initiating a clinical trial? What types of communication is necessary with the

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

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