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User Fee Add-Ons: Senate Bill Tweaks Orphans, Opioids, Patient Data

 
• By Nielsen Hobbs

Manager's amendment tells US FDA to issue more guidance for complex generics and tells GAO to report on progress towards global harmonization of data standards.

Capitol House

The user fee legislation that the Senate HELP Committee will markup on May 10 is mostly the bland, renewal-only document (a "clean" bill in legislative parlance) that circulated last month, but a manager's amendment released May 8 gives a sense of where senators, while not exactly getting their hands dirty, have decided to nudge FDA.

The additions have mostly avoided the controversial topics of the day, even as the bill now skirts the pricing debate...

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NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
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