21st Century Cures Bill Could Create More Prescriptive Rx Approval Standards For FDA
This article was originally published in The Pink Sheet Daily
Simplified and speedier drug approval process is focus for Reps. Upton and DeGette’s upcoming legislation – but getting there may mean more congressional micromanaging over FDA’s drug approval standards.
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Reps. Diana DeGette and Frank Pallone expressed disappointment with House Energy and Commerce 21st Century Cures bill; meanwhile Senate Republicans kick off their own reform process.
President Obama highlights potential for personalized medicine in his State of the Union address and will seek a “major increase” in research and development funding.
A move toward centralized institutional review board approval of study protocols could reduce clinical trial delays; House Energy and Commerce Committee also is looking at optimizing use of real-world data in the post-market setting.