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.
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Among those judged eligible are FDA rules governing adverse event reporting and the Unique Device Identification System.
Most FDA and CMS rules would sunset after 10 years unless action is taken by the agency under a new HHS proposed rule designed to enforce retrospective regulation review. Some experts worry this could allow an administration to skirt traditional notice and comment periods before rule rescissions. The implementation of the rule would likely look very different at FDA than at CMS, experts added.
White House says all guidances, as well as proposed rules, must be submitted to OMB for a determination whether they are major or minor.