The field of cell, gene and tissue therapies, now known as regenerative medicine, has seen tremendous and sustained growth in discovery and early-stage development in recent years, but the pipeline of late-stage candidates for commercialization has had trouble keeping pace – a circumstance that looks to be changing, helped by the US FDA’s efforts to establish a regulatory framework and the incentives of expedited review programs.
Regenerative Medicine Comes Of Age – In The Age Of COVID-19
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.
