FDA says resource capacity planning embedded; agency implements distinct models for complex and non-complex ANDAs

Josh Barton, director of resource capacity planning at the FDA, said the agency has continued to consolidate and sustain capacity-planning operations and to strengthen its analytical platforms and pipelines.

"This past year, our capacity planning efforts have really been focused on consolidating and sustaining the capacity planning operations," Barton said, describing technical work to migrate versions and strengthen pipelines. He said the work has included implementing distinct models for complex and non-complex abbreviated new drug applications (ANDAs), a development he called important for GDUFA planning.

Barton added that capacity-planning adjustments for PDUFA, BaSUFA and GDUFA remain a key tool to ensure appropriate staffing to address industry-submitted review workload in the future, but that those adjustments are not expected to change target revenue until review functions are fully restaffed. "The capacity planning adjustments... are not expected to adjust the target revenue for these programs until the review functions have been fully restaffed," he said.

Barton thanked capacity-planning staff for their work sustaining the capability and noted the updates have shortened over the years as the capability becomes part of routine business. He emphasized that the agency is working to ensure full staffing for the relevant review functions before relying on capacity-planning adjustments to change fee targets.

No specific timetable for staffing completion or concrete numerical staffing targets was given on the record. The remarks were informational and were followed by closing instructions about public comment and posting of materials.