PDUFA VII: Will Gene Therapy's Rise Influence Talks?
The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.
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'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.
Both sides want enhancements to deal with growth in cell and gene therapy, as well as work on regulatory decision tools and finance issues.
Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.