FDA shifts toward electronic submissions

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The FDA has announced that all electronic submissions to the Center for Drug Evaluation and Research division of the FDA must use the electronic common technical document (eCTD) format, effective Jan.1, 2008.

The eCTD is an electronic interface for industry-to-agency transfer of regulatory information that enables the creation, review, lifecycle management, and archiving of electronic submissions and meets a list of criteria that make submissions technically valid, according to the FDA.

The new format requirement applies to new drug applications, biologics license applications and investigational new drug applications.