In this section you will be providing the FDA with an overview of your product’s background, rationale, and development plan. Key topics that you should consider highlighting in this section, along with a brief description of what can be included under each section, are shown below.
Disease background | Unmet need and current treatments | Innovation and rationale | Development plan |
|---|---|---|---|
A comprehensive overview of the disease and its pathology | A description about what the treatments currently available for your target indication are and what/where the clinical needs are | An overview of the innovation and rationale for your product and how it tackles the unmet clinical need | A brief statement about the history of your product’s development and its status (Refer to Section: Regulatory Background) |