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
- 1The Enduring Role of Orphan Drug Exclusivity for Biologics ...
Orphan Drugs receive a 7-year period of exclusivity from product approval - effective on the date...
- 2Designating an Orphan Product: Drugs and Biological ...
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“...
- 3Court ruling in orphan drug lawsuit reframes outlook on ...
Under orphan-drug exclusivity, the FDA may not approve another sponsor's application for the same...
- 4Orphan Drugs in the United States - IQVIA
- 5Newly 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...
