Electronic Registration to Aid FDA's Quest for Enhanced Global Oversight
This article was originally published in The Gold Sheet
Executive SummaryWhat facilities produce what drugs for the U.S. market? FDA is committed to obtaining a more accurate answer to that question by requiring electronic registration and listing - and by knocking on doors if necessary. A registration fee could be coming, if pending legislation is any indication. Although the agency has long sought to improve its flawed paper drug registration and listing process, progress is much quicker with Congress reacting to fears of substandard ingredient suppliers in China. Under the new approach, all registered facilities will have unique numerical identifiers called DUNS numbers obtained from Dun & Bradstreet. Meanwhile, FDA is turning to commercial databases to clean up its list of drugs on the U.S. market - and flush out illegal unapproved drugs for targeted enforcement actions.
You may also be interested in...
Industry complained draft guidance would have made manufacturing establishment information harder to report, not easier.
Interactive map, charts provide details on our analysis of FDA 2009-2014 inspection results data showing that even as the agency responded to the threat of poor drug quality abroad, it was more successful at finding serious quality issues during its much more numerous domestic inspections.
FDA inspection results data show that even as the agency responded to the threat of poor drug quality abroad in fiscal years 2009-2014, it was more successful at finding serious quality issues during its much more numerous domestic inspections. Asian inspections were somewhat more likely to identify serious issues than US ones, while European inspections were much less likely to raise any, and neither identified nearly as many.