One question you may have is whether or not the eCTD format is mandatory.

The answer to that question is: not yet. In the future, however, electronic submissions will be mandatory. This is why FDA strongly encourages you to submit in eCTD format. Requirements for electronic submission shall be phased in according to the following schedule:

1. Twenty-four (24) months after publication of the final guidance: All original new drug application (NDA) and biologics license application (BLA) submissions; all new NDA and BLA efficacy supplements and amendments; all new NDA and BLA labeling supplements and amendments; all new manufacturing supplements and amendments; and all other new NDA submissions.

2. Thirty-six (36) months after publication of the final guidance: All original commercial investigational new drug applications (INDs) and amendments, except for submissions described in section 561 of the Federal Food, Drug, and Cosmetic Act.

* Reference: The PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 - 2017 document

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