Here we are in 2018, and to the surprise of some and the consternation of many, some paper applications are still alive and well. However, their days are numbered. The May FDA eCTD mandate is upon us. Is your company prepared to implement the FDA’s regulations for eCTD submissions of INDs, NDAs and DMFs?
Time is running out for an item that may require your regulatory compliance attention. By law, FDARA marketing status reports are due on or before February 14, 2018.
Nowadays the word “scan” is a bad word. Scanned documents are more difficult to read and often the quality is lower. Further, scanned documents do not allow search or copy and paste text. During an electronic review, the ability to search and cut and paste text are very useful. Sponsors are reporting more and more rejections if scanned documents are submitted.
While the online world has radically changed during the past 8 years, our approach of creating quality content has not. The eCTD Summit blog will continue to be a source of objective information on all things eCTD and regulatory submissions. Articles on the site are based on facts and stripped of bias. We want the site to be a trusted place our readers can regularly return to for updates on industry news, initiatives and best practices.
When selecting a system for cross-department viewing of eCTD submissions, as well as archiving, here are some important points you’ll want to give proper attention.