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