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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:

  • regulatory support
     

  • tax incentives
     

  • fee waivers
     

  • 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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