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Gene Therapy Oversight To Be Streamlined By US FDA, NIH

Executive Summary

Streamlining adverse event reports among reform ideas; NIH's Recombinant DNA Advisory Committee likely to drop review of more routine protocols.

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NIH Ends Gene Therapy Trial Reporting Requirements In Reg Streamlining Move

Trial protocols, annual reports, and adverse event reports on gene therapies will only go to US FDA under now-finalized amendments, a sign that the product category is maturing and can be regulated like other drugs and biologics.

US FDA's New Development Science Office Modeled On Modeling Office

Commissioner Gottlieb, who worked at FDA when modeling and simulation office was created and fostered growth of the techniques, expects that new drug development science office could do the same thing for biomarkers.

NIH Ends Gene Therapy Trial Reporting Requirements In Reg Streamlining Move

Trial protocols, annual reports, and adverse event reports on gene therapies now only go to US FDA, a signal that the products can be regulated like other drugs and biologics.

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