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Foggy On The Details: FDA Looks To OMB For 'Clarity' On What Constitutes A 'Major' Guidance Or Rule

Executive Summary

In mid-May a policy will kick in that requires all US agencies to send new rules and guidance documents to the Office of Management and Budget so it can determine whether they're "major" and should be voted on by Congress. Yet an FDA official said at MedCon 2019 on 2 May that the agency is still looking for more "clarity" on the subject. There are several draft guidances in the device center pipeline that will be affected by the OMB's oversight play.

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