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Use of "interdisciplinary committees" for guidance development urged by IMDMC in comments to FDA.

This article was originally published in The Gray Sheet

Executive Summary

FDA USE OF "INTERDISCIPLINARY COMMITTEES" FOR NEGOTIATED GUIDANCE DEVELOPMENT is advocated by the Indiana Medical Device Manufacturers Council in comments submitted by attorney Bradley Thompson (Indianapolis firm of Baker & Daniels) on the agency's proposed procedures for the development and use of guidance documents. For "certain regulatory subjects," IMDMC states, FDA should establish "interdisciplinary committees" -- composed of representatives from the agency, industry, patients, and academia -- to undertake a "negotiated guidance development process" similar to negotiated rulemaking procedures.



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