Accelerated Approval Could Expand As Alternative To Progressive Approval

CDER Director Woodcock says agency should issue internal and external guidance to promote consistent use of the pathway.

FDA wants to make a better case for increasing the use of accelerated approval, potentially as an alternative to implementing a new expedited approval mechanism.

In addition to saving the agency the inevitable headaches associated with implementing a new pathway, it also could quiet discussions about placing a new “Progressive” and/or “Exceptional” approval route into the agency tool box

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