Preparing for the Future, Getting Ready for eCTD

It will likely be four to five years before drug sponsors are forced to submit their investigational, new drug and biologic license applications via the electronic common technical document (eCTD) format. Nonetheless, companies — especially those that are new to electronic submissions — should prepare now, an industry expert says.

The eCTD requirement is expected to be part of the Prescription Drug user Fee Act (PDUFA) reauthorization, and mandates should kick in in 2016 or 2017, Antoinette Azevedo told listeners at a recent FDAnews webinar.

Azevedo encourages companies to get busy on eCTD budgets, vendor selection and validation.

The tool you need is here with FDAnews’ The eCTD Survival Guide: Strategies for Meeting the FDA’s New Deadlines. 

By 2017, the FDA will only accept electronically submitted new drug and biologics applications. That may seem like a long way in the future, but five years isn’t much time when you have to plan and budget for conversion to an all-electronic data system; evaluate and select appropriate hardware and software; implement and validate your new system; and test it to make sure it’s compatible with the agency’s system.

The time to get rolling is now. Order your copy of this must-have guide today.