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Electronic drug registration and listing process was a leading source of complaints last year

This article was originally published in The Gold Sheet

Executive Summary

Difficulty complying with a new requirement to register drug manufacturing facilities electronically was one of the 12 main reasons industry complained to the ombudsman in FDA's center for drugs in 2009. Prior to June 1, industry faxed or mailed paper forms to update FDA on which facilities were involved in producing which drugs. Afterward, they had to use a new electronic process ("The Gold Sheet," November 2008). "Many companies, especially small businesses, complained that the 13-step electronic process was too complicated and lengthy," the ombudsman, Virginia Behr, said in her annual report for 2009. One of the top reasons consumers and healthcare professional contacted the ombudsman was to report suspicions of contaminated and adulterated drugs. Behr also reported "far fewer" complaints last year about delays in responding to Freedom of Information Act requests, with the agency reducing its backlog by 12.4 percent.

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