Orphan diseases affect roughly 30 million Americans. These rare diseases often lack the right amount of medical attention and research, and thus there are a limited number of treatments and therapies available.
The Orphan Drug Act (ODA) was passed in 1983 to incentivize the development of treatments for rare diseases. When certain criteria are met, pharmaceutical companies can pursue an Orphan Drug Designation (ODD) to establish 7-year drug exclusivity upon entering the market, waive the Prescription Drug User Fee Act (PDUFA) fee, and receive other meaningful benefits to assist in their drug development program.
Download our Orphan Drug Designation white paper to learn more about the criteria required to apply for an ODD, the proper steps for submission to FDA, as well as the benefits of receiving an ODD.