Crackdown On Bad Regenerative Medicine Could Benefit Gene Therapy
US FDA to offer series of guidances on regenerative product development – and declares gene therapies eligible for RMAT – as enforcement against 'unscrupulous actors' continues.
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In interview with the Pink Sheet, Commissioner Gottlieb credits career staff, not his leadership, with many of the policy shifts.
Accelerated approval would help agency monitor gene therapies for durability and off-target effects, US FDA commissioner says.