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If, at any time, FDA determines that any of the grounds for withdrawal in section 911(j) apply, including a determination that the applicant, based on new information, can no longer make the demonstrations required under section 911(g) for a modified risk order, FDA is required to withdraw the order

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Radiation dosages are measured in sieverts - but because these are so big we're talking about millisieverts mSv (a thousandth of a sievert)