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Guidances are "not binding," FDA emphasizes in response to Indiana group's petition.

This article was originally published in The Tan Sheet

Executive Summary

FDA'S EXISTING POLICY APPEALS MECHANISMS EMPHASIZED in a preliminary agency response to a May citizen petition from the Indiana Medical Device Manufacturing Council (IMDMC) that asked FDA to take steps to eliminate so-called "informal rulemaking." In an Oct. 30 letter to attorney Bradley Thompson of the Indianapolis firm Baker & Daniels, which submitted the petition on behalf of IMDMC, FDA Deputy Commissioner for Policy William Schultz highlighted several existing mechanisms companies can use to appeal FDA actions they believe to be based on inappropriate application of guidance documents or other informal policy statements.
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