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FDA guidance document enforcement to be focus of Sept. 14 House Shays/McIntosh hearing.

Executive Summary

FDA GUIDANCE DOCUMENT USE WILL BE FOCUS OF SEPT. 14 CONGRESSIONAL HEARING to be held by two subcommittees of the House Government Reform Committee: Rep. Shays' (R-Conn.) Human Resources Subcommittee and Rep. McIntosh's (R-Ind.) Regulatory Affairs Subcommittee. The hearing, which will focus on FDA enforcement issues, specifically will examine the extent to which FDA requires compliance with guidance documents that are not promulgated as regulations.

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