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OUTLOOK 2021

Annual industry ranking and forecast

Regenerative Medicine Comes Of Age – In The Age Of COVID-19

Executive Summary

Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.

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Cell and gene therapy product activities also have increased CBER’s workload significantly and strained staff, the agency tells industry representatives.

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