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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Entities that already have received letters from the agency raising concerns about marketing unapproved products may not necessarily be the first to face enforcement actions, CBER official says.
US FDA is frustrated that few stem cell therapy makers are seeking regulatory approval of their products during the current enforcement grace period.