Orphan Drug Designation (ODD)
ODDSpecial status granted to drugs developed for rare diseases (affecting <200,000 people in US). Provides incentives including 7-year market exclusivity, tax credits, and reduced filing fees.
أمثلة
- Imatinib for CML (initially orphan)
- Nusinersen for SMA
- Over 5,000 designated, ~800 approved
هل تعلم؟
Special status granted to drugs developed for rare diseases (affecting <200,000 people in US). Provides incentives including 7-year market exclusivity, tax credits, and reduced filing fees.