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FDA MUST "INSULATE" PREMARKET REVIEW PROCESS FROM IMPACT OF FDA REFORM LEGISLATION -- REED SMITH SHAW & McCLAY ANALYSIS; HOUSE CONFEREES APPOINTED

This article was originally published in The Gray Sheet

Executive Summary

FDA must "insulate" its premarket review process from the potential "distractions" posed by the demands of implementing pending FDA reform legislation, an analysis of the legislation performed by the Washington, D.C. law firm of Reed Smith Shaw & McClay recommends. Noting the numerous regulations, guidances and reports mandated by the measure, the firm says "an unintended short-term effect of the FDA Modernization Act [S 830/HR 1411] may be to slow down the `nuts-and-bolts' application reviews of the agency." The analysis was co-authored by former FDA Associate Commissioner for Legislative Affairs Marc Sheineson.
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