COVID-19’s Damage To Gene Therapy Development May Last Years
US FDA's Peter Marks says the field is robust, but hedges on approval predictions for the coming years because of pandemic’s effect.
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Sponsors will receive additional agency interactions through the formal meeting process, as well as an option to ask clarifying questions later.
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.