Regulatory Experts: OMB Memo Could Drastically Slow FDA Guidances

April 12, 2019
Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry. The memo, released by OMB Acting Director Russell Vought on Friday (April 12), reaffirms the applicability of the Congressional Review Act (CRA), which requires federal agencies to send...

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