Can someone please explain what “Orphan drug”
Post# of 158091
(Total Views: 339)
Posted On: 10/21/2025 1:55:10 PM
Can someone please explain what “Orphan drug” is and means?? What does that designation do for the company?
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Supporting the development and evaluation of new treatments for rare diseases is a key priority for the FDA. The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including:
Tax credits for qualified clinical trials
Exemption from user fees
Potential seven years of market exclusivity after approval
l
The primary benefit being an FDA approval ???
=>>>
https://www.fda.gov/industry/medical-products...l-products.
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Supporting the development and evaluation of new treatments for rare diseases is a key priority for the FDA. The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including:
Tax credits for qualified clinical trials
Exemption from user fees
Potential seven years of market exclusivity after approval
l
The primary benefit being an FDA approval ???
=>>>
https://www.fda.gov/industry/medical-products...l-products.
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