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The Road To Restoring Credibility: How Maintaining A Good Reputation With FDA Can Be An Uphill Battle For Manufacturers – But It's Possible

This article was originally published in The Gray Sheet

Executive Summary

From our digital archives: Manufacturers can develop a bad reputation with FDA for a variety of reasons, including failing to systemically fix problems or follow through on commitments. “It’s tiresome, frankly, as a regulator, to have firms come in and pay lip service to the steps that they’re going to take, and then not follow up to demonstrate that they’ve taken those steps,” former CDRH Office of Compliance Director Steven Silverman said in December 2011. Two former agency officials also pointed out why FDA doesn’t trust some companies. Plus: A former Gambro Renal Products official explained how that firm's staff worked to change FDA’s perception of the company after it imposed an import ban on the firm in 2006.



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