US FDA's Drug Seizures Seen As Most Significant Aspect Of Stem Cell Crackdown
Former Office of Compliance and Biologics Quality Deputy Director Mark Schwartz says dishonest players have not often seen serious enforcement actions from the agency.
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In an interview with the Pink Sheet, Marks said the guidances on regenerative medicines make clear what the agency will be enforcing.
Taking cue from the regulators in the US and the EU, the Australian government is developing a policy to formally regulate the increasingly complex field of stem cell therapies. The new regulatory approach is to be supported by detailed guidance from the Therapeutic Goods Administration to help legitimate products gain approval.
US FDA to offer series of guidances on regenerative product development – and declares gene therapies eligible for RMAT – as enforcement against 'unscrupulous actors' continues.