Newly passed House bill could close orphan drug loophole ...
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The FDA can grant seven years of market exclusivity to a drug if it's intended to treat a condition affecting fewer than 200,000 patients in the U.S., ... Skiptomaincontent Pharma NewlypassedHousebillcouldcloseorphan
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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 (“...
- 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: - National ...
development in the rare disease space by offering grants, tax credits for clinical trial costs, w...
- 5Marketing 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...
