Industry, FDA Debate Safety & Access Issues Not Included In GDUFA Goals

An FDA official this week urged the generic drug industry to hold FDA accountable for meeting the metric goals outlined in the Generic Drug User Fee Amendments, not safety, access and transparency goals that industry would like the agency to meet but that were not negotiated. Issues like review times for applications that are not subject to negotiated metrics, FDA-industry communications and timely inspections have emerged as sticking points in ongoing dialogues between FDA and key stakeholder groups like the...