Describe the regulatory lifecycle of your drug (feel free to give it a name) including pre-clinical development, clinical testing, application for licensure, and post-marketing activities.

You are the Director of Regulatory Affairs for a company
that is developing a recombinant monoclonal antibody for the treatment of
cancer. Describe the regulatory lifecycle of your drug (feel free to
give it a name) including pre-clinical development, clinical testing,
application for licensure, and post-marketing activities. Provide a general
overview of each stage of the process, and be sure to address the following:
What pre-clinical characterization of the drug should be
done?
What interactions with the FDA are necessary at each
stage of development (e.g. formal meetings, applications, annual reports etc.)
What are the phases of clinical testing, and what
is the purpose of each phase? How many patients are involved at each stage
(generally)?
At what point(s) in the process do fees need to be paid
to the FDA (as per the Prescription Drug User Fee Act (PDUFA))?
How is this process different if your drug is granted
Orphan Drug status? Breakthrough Drug status?
What sections in the Code of Federal Regulations (21
CFR) apply to each stage of development for this particular type of product?

Please provide a ~2-3 page response including
citations for each section/question.
Be sure to answer each deliverable as it is listed in sections Just make sure each section is clearly labeled and identified. Think of it in terms of step by step for drug development. Use the attached and any other reputable government resources/laws/regualtions you can find.

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