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
- 1Orphan Drug Exclusivity Keeps Biosimilars Off the Market ...
Orphan Drug Exclusivity Keeps Biosimilars Off the Market, Study Says ... Investigators found that...
- 2Marketing 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...
- 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...
- 5Orphan Drugs in the United States - IQVIA
