FDA Piloting Electronic FARs as Focus Intensifies on Defect Data Mining

FDA is piloting an electronic Field Alert Report (FAR) system that could help foster improved defect detection, prevention, and mitigation, and further empower the agency’s ability to understand where the industry shortfalls are and the particular firms that need heightened enforcement attention.

Defect reports are getting increased scrutiny from FDA and other regulatory authorities as an important indicator of where the primary GMP concerns lie and where the agencies should be focusing attention to better leverage their limited enforcement resources.  The reports are one of several industry-wide metrics that FDA is considering using to compare the compliance positions of individual companies and help create a more flexible and rationalized review and inspection system (IPQ “The News in Depth” June 23, 2013).

FARs are required to be submitted when firms find potentially significant problems with products approved through new and abbreviated new drug applications (NDAs/ANDAs).  Reports must be submitted to district FDA offices within three days of a problem being identified, unless the problem has been resolved during that time.

In an early May Federal Register (FR), FDA announced its intention to pilot the electronic FARs and invited industry volunteers to participate.

FDA explained that the pilot is “intended to provide FDA with information to allow the agency to modernize the FAR submission and review pathway and permit integration with electronic archive filing systems.”

Under existing procedures, firms typically submit FARs via fax or scanned copy to their respective FDA district offices.  The district offices triage the reports and provide them to CDER for additional review and analysis.

The FR notice explains that, under the pilot program, participants will be able to send an electronic FAR simultaneously to the selected FDA district office and to CDER’s Office of Compliance, “allowing for improved coordination within the agency as well as more efficient reporting by industry.”

The pilot program is open to all NDA and ANDA holders, and no additional software or licenses are required.  The agency will also offer industry participants the opportunity to provide it with feedback regarding the use of the automated form.  Firms are asked to contact the district office where they are located to sign up for the pilot, if interested.

[CLICK HERE for the complete story.  Included is an analysis of the past five years of FARs data.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (Jonathan@ipq.org.)  For subscription/license information, click here.]

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