Revised FDA Enforcement Report Stresses Clarity, Data Accessibility

Posted 21 June 2012 | By Alexander Gaffney, RAC 

Regular readers of the US Food and Drug Administration's (FDA) weekly enforcement reports-the vehicle through which the agency publishes recalls initiated by or reported to FDA-will see a big change to the reports starting today.

On 21 June, FDA announced it has completed a planned revision of the reports to make information easier to understand, quicker to read and more accessible to technology. In an announcement in early June 2012, FDA said it planned to roll out a new enforcement report with the intent of delivering a "simpler, clearer report that encourages data download and analyses while also providing savings and encouraging future innovation for Government."

"Instead of the narrative report you see now, you will find a data-driven report encouraging innovative stakeholders to extract more intelligence out of the data and providing FDA a baseline as it moves forward in its efforts to integrate the Agency's compliance and enforcement data," explained FDA. "This data-driven report provides FDA a baseline as it moves forward in its efforts to integrate the Agency's compliance and enforcement data."

The new report shows all data in summary format and is easily searchable through a range of options, including product type, the recalling firm, recall classification, the recall's status, and the location of the recall. Previous iterations of the list, which FDA describes as a "narrative" approach, featured a lengthy set of descriptions and details which were difficult and time-consuming to search through.

Data is also downloadable in .CSV format, which allows for use in Microsoft Excel and other information processing software.

FDA said in a statement it hopes to improve upon the design further, and is actively soliciting feedback on the changes. In previous statements, it also said it hopes to make an additional change to the enforcement reports in the near future to allow it to provide advance notice of pending, unclassified recalls.

Read more:

FDA - Enforcement Report for June 20, 2012

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