FDA policy appeals mechanisms may get more publicity, FDA's Schultz tells IMDMC .
This article was originally published in The Gray Sheet
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" ("The Gray Sheet" May 22, p. 3). In an Oct. 30 letter to attorney Bradley Thompson (Indianapolis firm Baker & Daniels), who 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 that are believed to be based on inappropriate application of guidance documents or other informal policy statements.
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