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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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.
Will the US FDA agree to more structured communications amid its struggles with the existing meeting workload?