The US Food and Drug Administration is applying the principles of the platform technology designation to situations that may not technically qualify for the program in order to speed the approval of multiple indications for cell and gene therapies.
US FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals
CBER’s Nicole Verdun said the FDA is using the principles of the platform approach in situations that don’t qualify for the agency’s new incentive.
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