'Just Say It!' – New Streamlined Guidance Format Coming, FDA's Woodcock Says
US guidances will be shorter and use a series of bullet points to communicate key ideas, replacing the current longer and wordier format.
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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.
White House says all guidances, as well as proposed rules, must be submitted to OMB for a determination whether they are major or minor.
Updated Good Review Management Principles focus exclusively on “fundamental values and operational principles” underpinning the new drug review process – leaving nuts-and-bolts procedures to be spelled out elsewhere.