Orphan Drug Act
The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor. The combination of the product to treat the rare disease or condition must meet certain criteria. This status is referred to as orphan designation. Orphan designation qualifies the sponsor of the product for the tax credit and marketing incentives of the ODA. A marketing application for a prescription drug product that has been designated as a drug for a rare disease or condition is not subject to a prescription drug user fee unless the application includes an indication for other than a rare disease or condition.
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Optimal Clinical Supply Planning for Global Drug Development
Online training - supply chain risk - optimize clinical trial supply - risk management - supply simulation tool
Online training - supply chain risk - optimize clinical trial supply - risk management - supply simulation tool
Biomarkers for Drug Development: The Emerging Regulatory Landscape
Regulatory requirements - biomarkers development and implementation - drug development programs - PET Drugs - FDA guidelines
Regulatory requirements - biomarkers development and implementation - drug development programs - PET Drugs - FDA guidelines
Drug Safety Assessment and Risk Minimization in the Development Period
Drug safety training - factors to be considered - drug development - risk management - intellectual property - pharmacovigilance
Drug safety training - factors to be considered - drug development - risk management - intellectual property - pharmacovigilance