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
延伸文章資訊
- 1Marketing 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...
- 2Newly passed House bill could close orphan drug loophole ...
The FDA can grant seven years of market exclusivity to a drug if it's intended to treat a conditi...
- 3Designating an Orphan Product: Drugs and Biological ...
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“...
- 4ORPHAN DRUGS IN THE UNITED STATES: - National ...
development in the rare disease space by offering grants, tax credits for clinical trial costs, w...
- 5Court ruling in orphan drug lawsuit reframes outlook on ...
Under orphan-drug exclusivity, the FDA may not approve another sponsor's application for the same...
