The Priority Review

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Center for Drug Evaluation and Research

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  1. Regulation

    FDA announces support for forward compatibility of eCTD 4.0

    The FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research announced support for forward compatibility of Electronic Common Technical Document (eCTD) Version 4.0. This notice informs stakeholders that submissions based on eCTD 4.0 are supported for forward compatibility.