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New FDA Data Dashboard

Debra Topham

The FDA gave us a New Year’s present – with a new Data Dashboard.  They have created a contemporary — wow! yes contemporary! — and aesthetically pleasing dashboard to display publicly available data.  The dashboard covers four areas, Inspections, Compliance Actions, Recalls and Imports/Import Refusals, with data from 2009 thru 2018. The data is broken into broad buckets,  Biologics, Drugs,  Devices, Food/Cosmetics, Tobacco, and Veterinary — unfortutely food, dietary supplements and cosmetic data is all lumped together.


FDA Inspection

  • Includes completed and finalized inspections of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed. See also the FDA Inspections Database



Compliance Actions

  • Data pertaining to Warning Letters, Seizures, and Injunctions. The compliance actions disclosed include only finalized and completed actions and are primarily used in the domestic arena. Actions pertaining to foreign firms often take the form of import alerts, and are currently not reported in this Dashboard release.

  • Reminder, the FDA has archived many warning letters – searching FDA.gov site will not find archived letters please use the KnowledgeBank free tool to search for archived warning letters.



Recalls

Imports/Import Refusals.

  • Interestingly, the source of the import data is not clearly cited.


All in in all a great first step.

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