Statements (19)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory status
|
| gptkbp:appliesTo |
drugs for rare diseases
|
| gptkbp:awardedBy |
gptkb:European_Medicines_Agency
gptkb:U.S._Food_and_Drug_Administration |
| gptkbp:criteria |
no reasonable expectation of recovering costs through sales
disease affects fewer than 200,000 people in the US |
| gptkbp:duration_of_market_exclusivity_(EU) |
10 years
|
| gptkbp:duration_of_market_exclusivity_(US) |
7 years
|
| gptkbp:establishedBy |
gptkb:Orphan_Drug_Act_of_1983
|
| https://www.w3.org/2000/01/rdf-schema#label |
Orphan Drug designation
|
| gptkbp:provides |
tax credits
fee waivers market exclusivity |
| gptkbp:purpose |
encourage development of drugs for rare diseases
|
| gptkbp:relatedTo |
drug development
regulatory affairs rare disease |
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|