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Sponsors in denial?

2008 eCTD Train Wreck?

January 08, 2008

It’s been coming for a long time. Now it’s here. The FDA and the pharmaceutical industry adopt new processes imperceptibly. Deliberately. But as the new year begins, 2008 has at least one stark shift. As of now, electronic regulatory submissions to the U.S. authorities must use the electronic common technical document (eCTD) format. Officially, technically, waivers of…more...

July 21, 2019

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