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October 7, 2008
Sponsors in denial?
2008 eCTD Train Wreck?
Warren Perry of Qumas warns that some of the industry will be unprepared for the FDA insisting on its long-planned transition to the eCTD.
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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…
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