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Orphan Drug Products; Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (Form FDA 3671) OMB No. 09100167 SUPPORTING STATEMENT A. Justification 1. Circumstances Making the Collection
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Orphan drug products are medications that are developed to treat rare diseases or conditions that affect a small percentage of the population.
Manufacturers or sponsors of orphan drugs are required to file for orphan drug designation with the FDA in order to receive certain incentives.
To fill out orphan drug designation, manufacturers need to submit an Orphan Drug Designation Request Form to the FDA.
The purpose of orphan drug products is to provide treatments for rare diseases that may not otherwise receive attention from pharmaceutical companies.
Information such as the name of the drug, the rare disease it is intended to treat, and data supporting the drug's efficacy must be reported on orphan drug designation applications.
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