Rolling eCTD Submissions a Good Fit for Expedited FDA Programs

The idea of a rolling submission, or rolling review, for a Biologics License Application (BLA) or New Drug Application (NDA) is not new. In fact, the concept was introduced as the U.S. Food & Drug Administration (FDA) implemented the Modernization Act of 1997. A rolling submission is done in waves. Sponsors submit completed sections for … Continued

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