Orphan Drug Act: Overview | Practical Law
A Practice Note providing an overview of the Orphan Drug Act (ODA) as it applies to commercial sponsors that develop drugs or biologics to treat rare diseases or conditions. This Practice Note discusses ODA incentives, including marketing exclusivity, tax credits, user fee waivers, and clinical research grants. This Note also discusses key considerations for a sponsor submitting a request for orphan-drug designation to the Food and Drug Administration (FDA).