Market exclusivity: orphan medicines | European Medicines ...
文章推薦指數: 80 %
Expiry of market exclusivity ... When the period of market exclusivity for an indication ends, the orphan designation for that indication expires and the European ... Skiptomaincontent Menu Medicines Medicines Search Download Whatwepublishandwhen
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...
- 2Orphan drug - Wikipedia
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because the...
- 3Designating an Orphan Product: Drugs and Biological ...
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“...
- 4Marketing 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...
- 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...