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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Nonclinical testing questions should be answered in a pre-IND meeting, rather than the new Type D session. A US FDA Center for Biologics Evaluation and Research official also indicated support for alternatives to animal testing when possible.
After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?
Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.
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.