US FDA's Biologics Center May Get Its Day In PDUFA VII
Multiple stakeholders call for CBER to receive more prescription drug user fee funds amid growing cell and gene therapy popularity.
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More patient-centric trial designs also may be coming due to pandemic-related advances, Marks says.
Former chief of White House Domestic Policy Council advises cell and gene therapy companies on strategies for promoting enhanced FDA review capabilities as part of Prescription Drug User Fee Act reauthorization negotiations.
Both sides want enhancements to deal with growth in cell and gene therapy, as well as work on regulatory decision tools and finance issues.