Drug Development Process – From Discovery to Marketing

Overview: This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. We will begin by reviewing the contents of an Investigational New Drug (IND) application, and then follow the process of an IND submission. Next, the contents and approval process of an NDA submission will be discussed. […]

Orphan Drugs in the USA

Orphan drugs are drugs that are exclusively developed and used for treating rare diseases. Orphan drugs are not researched and developed for widespread use, since by their nature, they are meant only for rare diseases. Since by definition, a rare disease is not likely to have too many patients; orphan drugs are limited in their […]