Ann: PharmAust to present at NWR Virtual Healthcare Conference, page-125

From the FDA website
(https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions#:~:text=Orphan%20drug%20designation%20provides%20incentives,of%20market%20exclusivity%20after%20approval)

Incentive programs for rare disease medical products

The Orphan Drug Designation program provides orphan status to drugs and biologics for rare diseases that meet certain criteria. Orphan drug designation provides incentives including:

• Tax credits for qualified clinical trials
• Exemption from user fees (Dec 2022: almost $3 million for a new drug)
• Potential for seven years of market exclusivity after approval

FDA also administers grant programs to provide funding for research on rare diseases. These grant programs include:

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The Rare Neurodegenerative Disease Grant program awards grants and contracts to public and private entities to cover costs of research and development for interventions intended to prevent, diagnose, mitigate, treat, or cure ALS and other rare neurodegenerative diseases in adults and children.