US FDA May Start Missing ANDA User Fee Goals – In Order To Speed Approvals
Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.
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Kathleen Uhl says applicants can avoid RTRs by conducting quality checks before submission, but sponsors may have difficulty changing their approach because of how fundamental application speed is to their business model.
OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.
Office of Generic Drugs Director Kathleen Uhl calls a two-cycle approval timeline a realistic expectation for ANDA approval, but would not say that most ANDAs will fall into the paradigm.