FDA Orphan Drug Designation

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 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.

Orphan Drug Designation White Paper

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How Regulatory Affairs Consultants Can Speed Up Designation

Through the collaboration with Regulatory Affairs Consultants, sponsors have a team of experts working to ensure their application is properly noted, detailed, and free of errors. BioPharma Global Consultants have helped numerous pharmaceutical companies receive Orphan Drug Designations. Moreover, BioPharma Global has a 100% FDA and EMA submission success rate when sponsors follow our regulatory expert’s guidance. In the end, utilizing Regulatory Affairs Consultants help eliminate the natural bottlenecks and delays that many sponsors face when going through the ODD submission process by themselves. 

Who is BioPharma Global?

BioPharma Globalis a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A/B/C meeting assistance, IND filings, or electronic submissions, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.