The Enduring Role of Orphan Drug Exclusivity for Biologics ...
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Orphan Drugs receive a 7-year period of exclusivity from product approval - effective on the date of FDA approval of a marketing application. For ... Blog WelcomeOurFirmPracticeAreasHatch-WaxmanExclusivityStrategicProductDevelopmentBCPIA:BeyondHa
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...
- 3Market exclusivity: orphan medicines | European Medicines ...
Expiry of market exclusivity ... When the period of market exclusivity for an indication ends, th...
- 4The Enduring Role of Orphan Drug Exclusivity for Biologics ...
Orphan Drugs receive a 7-year period of exclusivity from product approval - effective on the date...
- 5Orphan Drug Exclusivity Keeps Biosimilars Off the Market ...
Orphan Drug Exclusivity Keeps Biosimilars Off the Market, Study Says ... Investigators found that...
