Executive Briefing Series (formerly The Food & Drug Letter)

June 15, 2012

Countdown to 2017: Start Early to Build an FDA-Compliant eCTD System

Beginning in fiscal year 2017, drug and biologics makers must be ready to submit to the FDA in electronic form all documents related to new drug applications (NDA), biologics license applications (BLA) and investigational new drug (IND) applications.

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