Trimming The Tree: What’s In The PDUFA Legislative Package – And What’s Out
The must-pass bill has many FDA policy ornaments hanging from it, but the version released by Democratic and Republican committee leadership has notable absences as well, including Cures 2.0.
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Oncology Center of Excellence Director Richard Pazdur asked whether the FDA should have more conversations with sponsors about site selection and percentages of US participants.
The draft bipartisan user fee reauthorization bill includes more than 40 ride-along provisions to make changes at the US FDA. But there are at least three other bills moving in Congress that also make FDA reforms.
Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings
Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.