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What is an Orphan Drug Designation and why it Matters
The FDA Orphan Drug Designation is a regulatory pathway that encourages the development of treatments for rare diseases.
It offers advantages such as:
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regulatory support
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tax incentives
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fee waivers
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seven years of market exclusivity
For patients, an ODD can mean faster access, formal recognition of a treatment, and a higher likelihood of reimbursement.
For more information visit the FDA website on the link right here:
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