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# ORA Reorg’s Impact on Drug Inspections: Cavazzoni
- URL: https://www.fdaweb.com/ora-reorgs-impact-on-drug-inspections-cavazzoni/
- Published: 2024-05-08T12:00:00.000Z
- Updated: 2026-09-14T14:30:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156938

CDER director **Patrizia Cavazzoni** says the reorganization of FDA’s Office of Regulatory Affairs regarding inspection activities will create a “unified compliance discipline and program that will reside within the Center and work hand in hand with the Office of Regulatory Affairs and the inspectorate.” Providing an online update to the Alliance for a Stronger FDA 5/7, Cavazzoni said the agency is putting a lot of effort into thinking about the work planning aspects of inspections and deploying inspectors.

Cavazzoni said the reorganization is focusing a lot of effort on modernizing the training curriculum for the investigators “because there are a lot of technological advances, not only in manufacturing facilities, clinical trial execution, and with the advent of AI and so on, and so we have to make sure that our training curriculums keep pace with those advances.” She said there is also greater attention being paid to finding ways to retain FDA’s most experienced investigators in addition to hiring new investigators. “But you know, it is critically important that we retain our most experienced investigators because even if we hire new investigators, it takes years and years and years for that person to achieve that level of proficiency. And so we’re talking internally on how we can do that.

The investigators' job is the most difficult job at FDA, Cavazzoni acknowledged while calling them heroes for what they do. “And particularly those who have to travel all over the world for foreign inspections have a very, challenging schedule, and we need to **(1)** make sure that we reward them accordingly, and **(2)** try to find ways to make their job easier, for instance, by making their travel planning easier and by doing everything that we can to make sure that they are supported to the maximum extent around inspections,” she continued. “And so, I see that as absolutely critical because without the investigators, we really cannot run the programs at CDER.”

Asked to comment about drug shortages, Cavazzoni said the agency is seeing more drug shortages than normal and that they are lasting longer too. “They’re more complex to resolve and that’s because we have less and less resiliency in the supply chain,” she said. Drug shortages and their mitigation are now part of the inspection modernization efforts, she added, noting that FDA is piloting an approach where there’s more communication between the investigators, the shortage team, and the compliance team before inspections, during inspections and after inspections so that investigators understand the context of a facility and what is being made in that facility.

“We strongly encourage manufacturers,” she continued, “not to stop manufacturing as a result of any inspection.” She said some manufacturers will shut down a line because of what they are hearing during an inspection. “We really want manufacturers to call the Drug Shortage Surveillance Team immediately because we want to start problem-solving with manufacturers as soon as possible during the inspection, or over the course of the inspection, so that we can try to put in place some of the mitigation approaches that we have to make sure that we don’t find ourselves with manufacturing stoppages of essential drugs like we have seen over the past year,” she said.