FDA has downgraded its expectations for usage of its 483 dispute resolution procedure
This article was originally published in The Gold Sheet
Executive Summary
At the request of industry, the agency issued draft guidance in September 2003 outlining a two-tiered formal process for resolving scientific and technical disputes that arise during inspections. The agency later estimated that every year, 25 companies would file a Tier One request and five would appeal to Tier Two. Based on the final guidance, published Jan. 12, 2006, FDA estimated in a Jan. 22, 2008, Federal Register notice that there would be only two Tier One requests and one Tier Two appeal in any given year