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October 01, 2010 (Vol. 30, No. 17)

Orphan Drug Changes Brewing at the FDA

Initiatives to De-Risk Drug Development Could Include Redesigning Clinical Trial Requirement

  • There is an initiative under way to revamp the way FDA approaches orphan drug development that goes above and beyond the 1983 Orphan Drug Act. The 2010 Brownback/Brown amendment was created as a market-based approach to address rare and neglected diseases by incentivizing biotech and pharmaceutical companies to invest ...

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