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Crackdown On Bad Regenerative Medicine Could Benefit Gene Therapy

Executive Summary

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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US FDA’s Stem Cell Clinic Enforcement Takes A Hit With Loss In California Case

Federal judge denies government’s request to permanently enjoin California stem cell clinic from administering unapproved stromal vascular stem cell treatments, concluding they are not ‘drugs’ under the FD&CA. Ruling runs counter to decision in similar case involving a Florida stem cell clinic.

US FDA’s Stem Cell Clinic Enforcement Takes A Hit With Loss In California Case

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Unapproved Cell/Tissue Product Enforcement Discretion Ends; How Hard Will US FDA Crack Down?

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