New OMB review process could impede FDA issuance of guidance documents

Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents.

On 11 April 2019 the Office of Management and Budget (OMB) issued a Memorandum for the Heads of Executive Departments and Agencies (Memo) that establishes new procedures for federal agencies that issue guidance documents, including FDA.

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