Court ruling in orphan drug lawsuit reframes outlook on ...
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Under orphan-drug exclusivity, the FDA may not approve another sponsor's application for the same drug for the same indication, unless the ... Healio News Rheumatology PracticeManagement
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- 1Market exclusivity: orphan medicines | European Medicines ...
Expiry of market exclusivity ... When the period of market exclusivity for an indication ends, th...
- 2Court ruling in orphan drug lawsuit reframes outlook on ...
Under orphan-drug exclusivity, the FDA may not approve another sponsor's application for the same...
- 3Orphan Drug Exclusivity Keeps Biosimilars Off the Market ...
Orphan Drug Exclusivity Keeps Biosimilars Off the Market, Study Says ... Investigators found that...
- 4Marketing Exclusivity for Drug Developers: What is it ...
Orphan drug exclusivity (ODE; 21 CFR 316.31) is used as an incentive to promote the development o...
- 5Orphan Drugs in the United States - IQVIA