Marketing Exclusivity for Drug Developers: What is it ...
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Orphan drug exclusivity (ODE; 21 CFR 316.31) is used as an incentive to promote the development of products intended to diagnose or treat rare ... HomeResourcesBlogTypesofMarketingExclusivityinDrugDevelopment ExploreOurBlog
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- 1Orphan Drug Exclusivity Keeps Biosimilars Off the Market ...
Orphan Drug Exclusivity Keeps Biosimilars Off the Market, Study Says ... Investigators found that...
- 2Designating an Orphan Product: Drugs and Biological ...
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“...
- 3Orphan Drugs in the United States - IQVIA
- 4Newly 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...
- 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...
