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User Fee Package Offers FDA Reforms From A House Wary Of FDA Power

 
• By Derrick Gingery

House drafters’ dissatisfaction with FDA’s performance is evident in several provisions of draft user fee legislation. The agency would be required to finalize some guidances within a year of issuing a draft, which likely would provide more predictability for industry.

What a difference five years makes. The last round of use feer reauthorization, in 2007, gave FDA powers – the REMS safety program – that it wasn’t particularly asking for and had a hard time wielding at first.

In this round, the agency is asking for some specific authorities, but it may not get them, at least if the discussion draft of omnibus user fee legislation...

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