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# CDER, ORA Concept of Operations Being Implemented
- URL: https://www.fdaweb.com/cder-ora-concept-of-operations-being-implemented/
- Published: 2017-08-31T12:00:00.000Z
- Updated: 2026-09-14T22:45:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139521

FDA commissioner **Scott Gottlieb** says CDER and the Office of Regulatory Affairs (ORA) are implementing a “new, historic concept of operations agreement to more fully integrate the drug review programs with the facility evaluations and inspections for human drugs. This new collaboration is a model for how we’ll modernize other parts of our organization to better achieve our mission.”

Writing in an *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2017/08/new-steps-to-strengthen-fdas-inspection-and-oversight-of-drug-manufacturing/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), Gottlieb says the agreement (link to agreement in post) leverages two efforts to ensure alignment between FDA’s field professionals and its review staff. The first effort uses “integrated quality assessment” teams to enable a closer consideration of all elements that create risk, including the drug substance, the drug product, manufacturing processes, and the state of the facilities being regulated.

The second effort is a structural realignment of ORA that moved its geographically organized staff and management into program-aligned commodity areas, more closely mirroring FDA’s organization model of Centers and regulated industries. “This step enhanced the integrated quality assessment,” Gottlieb writes, “and the new concept of operations that operationalizes these approaches, by enabling better alignment between our field professionals and the review staff who evaluated the products that are being manufactured in the facilities that we inspect.”

The new concept of operations outlines the responsibilities and workflow that CDER and ORA employees will follow, the commissioner says. The new model covers both pre- and post-approval inspections, surveillance inspections, and for-cause inspections at domestic and international drug manufacturing facilities that FDA oversees.

The post says that the improved inspection efficiency will help the agency meet its expanding commitments in a more complex environment, and fulfill its public health goals, including commitments made in GDUFA reauthorization to communicate final surveillance inspection classifications to facility owners within 90 days of an inspection.

“We hope that by communicating more quickly with product developers when manufacturing problems are identified,” Gottlieb concludes, “this agreement will help make inspectional issues less likely to cause approval delays or prolong the time it takes to get important products to patients who can benefit from them. As we continue to implement this new structure, we may update other related aspects of our inspectional programs, and how we organize our regulatory activities.”