Gene Therapy Guidance From US FDA Likely Needs Updating Sooner Rather Than Later
CBER Director Peter Marks says the "half-life" for the existing six gene therapy guidances likely is two to three years due to the fast pace of scientific discovery.
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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.
US FDA Recommends Use Of Pre-Built Facilities To Ease Scale-Up Process For Cell And Gene Therapies
As applications for expedited review of cell and gene therapies soar, it is important for their sponsors to take certain steps to enhance prospects for smooth commercial scale-up, the director of US FDA’s center for biologics suggests.
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.