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(a) All information and facts submitted under this component need to be transmitted to FDA electronically in accordance with § 207.61(a) Except if FDA has granted a request for waiver of this need previous to the date on which submission of this sort of info is thanks. Submission of a ask for for waiver won't excuse timely compliance Along with th
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(a) All info submitted under this aspect should be transmitted to FDA electronically in accordance with § 207.61(a) unless FDA has granted a ask for for waiver of the prerequisite ahead of the date on which submission of these kinds of details is owing. Submission of the request for waiver will not justification timely compliance Together with the
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