US FDA Guidance Production May Be Slowed By New OMB Review Requirement

White House says all guidances, as well as proposed rules, must be submitted to OMB for a determination whether they are major or minor.

White House

The US FDA's work over the years to speed production of industry and stakeholder guidance may be curtailed by a White House directive requiring the Office of Management and Budget review all of them before they are released.

Agency guidance, in addition to proposed and final rules, will undergo OMB review to receive an economic impact determination, which could allow congressional review of the document. OMB reaffirmed the...

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