CDER director on accelerated approval reforms and a court decision that will 'send a chill' across rare disease drug development
At the second of two hearings before the Senate Health, Education, Labor & Pensions Committee on the must-pass legislation (by the end of September) regarding the funds from biopharma industry applications that will keep the FDA afloat over the next five years, CDER director Patrizia Cavazzoni raised particular concerns about a recent court decision while laying out several requests for congressional accelerated approval reforms.
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