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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PDUFA VII Communications: Earlier PMR Talks, Formal Meeting Additions
Sponsors will receive additional agency interactions through the formal meeting process, as well as an option to ask clarifying questions later.
PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.
CBER Proposes Increasing Cell, Gene Therapy Staff In PDUFA VII
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.