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?