Fostering Orphan Drugs

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To foster the development of treatments for undertreated and rare conditions, FDA grants orphan drug designation to drugs and biologics that treat, prevent, or diagnose diseases that affect fewer than 200,000 people in the United States or drugs that meet certain cost recovery provisions (1). This designation comes with incentives such as tax credits, user fee exemptions, and market exclusivity. To receive such designation, sponsors must submit requests and present data to support the request.

BioPharm International asked Judith Jones, FRSC, Director Regulatory Affairs, Global Regulatory Affairs, Catalent, and Matthew Mollan, RPh, PhD, Regional Head of Operations, Early Phase Development North America, Catalent, about the specific ways contract development and manufacturing organizations (CDMOs) can assist sponsors in developing, applying for, and manufacturing orphan drugs.

Read this article in BioPharm International's Partnerships for Outsourcing eBook.

About the author

Susan Haigney is managing editor at BioPharm International.

Article details

BioPharm International
eBook: Partnerships for Outsourcing
May 2022
Pages: 28–31

Citation

When referring to this article, please cite it as S. Haigney, “Fostering Orphan Drugs,” BioPharm International Partnerships for Outsourcing eBook (May 2022).