FDA Launches New Filer Evaluation Process
In a letter to former NCBFAA President Geoff Powell, the Food and Drug Administration (FDA) announced that it has now completed its procedure for revamping the Filer Review process. According to FDA, the new process is now in effect nationally and is the method that will be used for conducting all filer evaluations. Here is a copy of the procedure along with a flow chart of the process and a chart giving examples of how FDA will determine the severity of data transmission errors during a review.
The changes in the filer review procedure evolved over the past nine years, with the close involvement of NCBFAA’s Regulatory Affairs Committee (RAC). The process was painstakingly slow. Yet, the agency listened. They significantly revised earlier proposals due to NCBFAA input. The new process is more transparent. For the first time, FDA evaluators must differentiate between minor errors and substantive errors. The new guidelines also recognize the difference between filer errors and importer errors – a critical distinction that was previously lacking.
Before launching the new guidelines, the FDA asked NCBFAA members to participate in a pilot to test and evaluate the new process, allowing the agency to receive feedback from the participating entry filers and the FDA evaluators.
NCBFAA’s work is not done. We continue to press FDA to develop a more reliable process for determining product codes and to allow an optional company-wide review for brokers who prefer that approach. And, as the process is implemented nationwide, trouble spots will no doubt occur, requiring continued communication with the agency to improve the process. NCBFAA and the RAC committee welcome your input as you experience the new filer review process.
A Big Thanks to Roger Clarke, Chairman Emeritus, NCBFAA RAC
When the FDA first started talking about changes to the Filer Review guidelines almost 10 years ago, it was Roger Clarke’s voice that stood out. His persistence, energy and insight guided the agency’s work, giving them a clear understanding of the industry’s perspective and prodding the agency relentlessly when the effort bogged down. While the final process is not perfect by any means, the Filer Evaluation guidelines released this week are a significant improvement and a big step forward, reflecting important NCBFAA priorities. This could not have happened without Roger’s leadership and vision.
© , NCBFAA, Washington D.C. Monday Morning eBriefing. Originally published [10/22/2018]. www.ncbfaa.org. Reprinted by permission.