Designating an Orphan Product: Drugs and Biological ...
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The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon ... Skiptomaincontent SkiptoFDASearch Skiptointhissectionmenu Skiptofooterlinks Inthissection: Devel
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- 1Court ruling in orphan drug lawsuit reframes outlook on ...
Under orphan-drug exclusivity, the FDA may not approve another sponsor's application for the same...
- 2The Enduring Role of Orphan Drug Exclusivity for Biologics ...
Orphan Drugs receive a 7-year period of exclusivity from product approval - effective on the date...
- 3Designating an Orphan Product: Drugs and Biological ...
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“...
- 4Orphan drug - Wikipedia
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because the...
- 5Market exclusivity: orphan medicines | European Medicines ...
Expiry of market exclusivity ... When the period of market exclusivity for an indication ends, th...
