FDA is upgrading its field alert report (FAR) system to provide for secure electronic submission of the reports, simultaneous transmittal to the appropriate district office and the Center for Drug Evaluation and Research (CDER), and unique identifiers for each report.
The new system will be launched as a pilot with voluntary participation by industry, and is expected to begin by the end of the year. It is the product of an “improvement project” done jointly by CDER’s Office of Compliance (OC) and the Office of Regulatory Affairs (ORA).
FDA is moving to create a more efficient and effective field alert reporting process in the context of the concerns it has been voicing in 483s and follow-up enforcement actions with industry noncompliance with its FARs responsibilities (IPQ “The News in Depth” May 8, 2012).
At a Global Outsourcing Conference (GOC) co-sponsored by Xavier University and FDA in late September in Cincinnati, Ohio, Office of Manufacturing and Product Quality (OMPQ) Director Steven Lynn explained that the project will be implemented in four phases over the next two years.
“Each phase will be rolled out incrementally in order to prevent disruption of business operations at ORA and CDER,” he explained. The gradual transition will allow firms “the opportunity to participate in standardization of the field alert reporting form, fields, and manufacturing data reported in the FARs.”
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