Friday, September 23, 2022 10:31:44 AM
""- Seven-year marketing exclusivity to the first sponsor obtaining FDA approval of a
designated drug
- Tax credit equal to 50% of clinical investigation expenses
- Exemption/Waiver of PDUFA application (filing) fees
- Assistance in the drug development process
- Orphan Products Grant funding
Eligibility A previously unapproved drug may be eligible for orphan drug status if it meets
the definition of an orphan drug and is:
- A previously unapproved drug
- A new orphan indication for an approved drug
- The “same drug” as one already approved but with a potential to be “clinically superior”
https://www.fda.gov/media/83372/download
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