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OMB to review FDA guidance

Executive Summary

The Office of Management and Budget issues a Jan. 18 bulletin to executive branch departments and agencies establishing policies and procedures for the development of significant guidance documents using FDA's guidance procedures as a model for these "good guidance practices." Each agency must designate an office to receive and address public complaints that the agency is not following procedures in the bulletin or is "improperly treating a guidance document as a binding requirement." The White House issues an executive order in conjunction with the OMB bulletin clarifying that OMB has authority to require notice and review of agency guidance documents...

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