The product to be developed is a monoclonal antibody. Your firm, ABC Biologicals inc. is developing a proprietary monoclonal antibody to treat cutaneous T-cell lymphoma, a cancer of white blood cells. This biopharmaceutical product is a humanized monoclonal antibody that targets and bind specifically to a cell surface molecule, CD545. The molecule, developed in your laboratory, has been characterized in research and has been shown, in a transgenic mouse model, to bind to cancer cells, leading to their death. To be effective in mice, the product is given by subcutaneous injection. Your firm now wishes to develop the monoclonal antibody product and apply for market approval.

Planning the regulatory approach and operational elements requires many skills and planning from multiple experts. Regulatory intelligence is conducted, followed by a draft plan. Finally, all sections of the PDP are reviewed to ensure that each is consistent and compliant with the current regulatory requirement.

Please address and POST your answers for the following questions.

1- Describe what is known about your monoclonal antibody product or a similar product (predicate) from the regulatory literature.

2- Identifies potential regulatory routes of approval, both USA and foreign, used to develop similar or predicate products.

3- Discuss how the national political environment may or may not be supportive of this product and lists potential state, local, or cultural practices or laws that might be unfavorable to such a product or indications.

4- Each product falls under one or the other office at FDA. Describe which office or division at FDA is likely to review your product. Explain how your product will fall into the scheme of FDA. Where will you submit applications within FDA?

5- Will market approval be sought, initially, in the United States alone and/or in other countries? Describe your plans to submit marketing applications in each chosen country.

6- For this product, outline the elements of the Investigational New Drug application (IND), in either IND or Common Technical Document format, as intended for FDA.

7- What FDA guidance documents are most important for your firm to consider this product and indication?

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