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# FDA Releases More Details on CDER/ORA Inspection Agreement
- URL: https://www.fdaweb.com/fda-releases-more-details-on-cder-ora-inspection-agreement/
- Published: 2017-08-25T12:00:00.000Z
- Updated: 2026-09-14T22:43:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139475

FDA has released more details on a CDER and ORA “concept of operations” agreement to integrate facility evaluations and inspections for human drugs ([see earlier story](https://www.fdaweb.com/cder-ora-pen-operational-agreement-for-inspections/)). The agreementoutlines responsibilities and the workflow for pre-approval, post-approval, surveillance, and for-cause inspections at domestic and international facilities. It will allow the two organizations to “more effectively manage the growing complexity of the pharmaceutical landscape,” the agency says.

After first denying ***FDA Webview***’s request earlier this week for access to the agreement, the agency reversed its decision and provided it in its entirety. The [21-page document](http://www.fdaweb.com/download.php?file=Concept%5Fof%5FOperation%5Ffor%5FFacility%5FEvaluation.pdf) discusses the operating model for each type of inspection. It notes that the concept of operations will also serve as a “foundational component as the pharmaceutical program develops new tools and techniques for assessing pharmaceutical quality (e.g., the New Inspection Protocol Program).” Standard operating procedures are under development to define ORA’s and CDER’s roles under the agreement, it says.