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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White House says all guidances, as well as proposed rules, must be submitted to OMB for a determination whether they are major or minor.
US guidances will be shorter and use a series of bullet points to communicate key ideas, replacing the current longer and wordier format.
Court rules that reps’ nonbinding commitments from physicians to prescribe drugs constitute a sale and thus make them outside sales employees who are exempt from overtime. Court also rebukes Labor Department’s policy change outside of rulemaking.