Globally, there is a need for orphan drug research, development, and approval for underserved patient populations who have diseases that affect very few individuals. While this patient population has been largely ignored, some pharmaceutical companies have built their research pipeline around these patients. Receiving orphan drug designation and approval confers many benefits to the developer to compensate for the development costs of the drug. This web seminar will explore which countries allow orphan drug designations, the application requirements, population limits and how to support this number, how the applications are the same, who to submit the application to, if and when the application can be changed, and how it needs to be supported over the development process.
