FDA aligns Inspection and Regulatory Affairs Systems

Recommendation

7/8 May 2024

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In a post, Commissioner Scott Gottlieb explains the FDA's plans to better coordinate regulatory affairs and field inspection activities to strengthen inspection and oversight of drug manufacturing worldwide. To achieve this goal, the authority plans to focus its activities more on global programs and less on geographic regions. To achieve this goal, the FDA's Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) will work closer together. In this co-operation, the two offices are implementing a new "concept of operations agreement". With this agreement the drug review programs should be better aligned with the facility evaluations and inspections for human drugs: "This new, team-based approach aligns field and review staff so that we can make closer consideration of all elements that create risk including the drug substance, the drug product, manufacturing processes, and the state of the facilities we regulate" Scott Gottlieb pointed out.

In parallel, the Office of Regulatory Affairs (ORA) gets a structural realignment. ORA's previous geographically organized staff and management is moved into so-called "program-aligned commodity areas".  This puts ORA's structure on par with the organisational system of FDA's centres. The advantage is obvious: A better alignment between field professionals and the review staff who evaluates the products are enabled. "Our inspectional force will benefit from insights that might be offered by the review teams who have carefully evaluated products being manufactured. Meanwhile, our review staff will benefit from the deeper understanding they will glean through more direct and regular contact with the professionals who are inspecting facilities" Scott Gottlieb said.

With this increased sharing of information and better co-operations, FDA increases also its availability for a better oversight of drug manufacturing.

Please also read the blog entry "New Steps To Strengthen FDA’s Inspection And Oversight Of Drug Manufacturing" by Commisioner Gottlieb.