Congress Already Preparing For User Fee Bills
Multiple congressional offices attended a briefing on GDUFA III with FDA and industry officials, suggesting plans for the must-pass bill already are in the works.
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Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.
Final commitment letter preparations now under way as revenue issues are resolved.
The popular patient-focused drug development model for new drugs might not fit for generics, in part because the affected patient groups would be much larger.