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.
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Unpublished And Under Review? US FDA’s CBD Policy Draft Guidance Still Has Industry Talking
Supplements containing hemp-derived cannabidiols aren’t typical products subject to FDA’s regulatory oversight, and the document stating its thinking on enforcement in the market submitted to the Office of Management and Budget isn’t a typical draft guidance.
White House Advances War On 'Guidance'; FDA Not Target, But May Feel Ripple Effects
US FDA's efforts to enforce against regenerative medicine and other gray market products might be collateral damage in Trump administration's latest attack on the perceived abuse of powers by regulatory agencies.
Two Months To Add Two Words – Biosimilar Supplement Review Times May Be Hindering Uptake
Biosimilar supplement approvals by the US FDA take on average about five months as sponsors request easier and quicker ways to update labels.