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Category Archives: eCTD
Clinical Study Reports to STFs
When working with sponsors who are new to eCTD submissions, one of the most common questions we get is, “What is a Study Tagging File and why do we need one for each clinical study report?” To explain the importance … Continue reading
Posted in eCTD, FDA, Guest Posts
Tagged clinical study report, eCTD, EMA, FDA, GlobalSubmit, Health Canada, Japan, STF, study tagging files
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Is FDA Issuing More Refuse-to-File Letters?
The June 2011 issue of Nature Reviews: Drug Discovery (volume 10, page 403) includes an interesting news brief regarding the apparent increase in Refuse-to-File (RTF) letters being issued by FDA in recent years. In a review of publicly available … Continue reading
Posted in eCTD, FDA, Regulatory Strategy
Tagged Cato Research, clinical research, CMC, eCTD, FDA, IND, NDA, refusal to file
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Health Canada Expands Acceptance of eCTD Submissions
Image via cellularhealthcanada.com Last week, Health Canada (HC) issued a Notice to to announce an increase in the types of submissions being accepted by the regulatory authority in the eCTD electronic-only filing format. Effective immediately, HC now also accepts two … Continue reading
Free Webinar – FDA Review Process for eCTD Submissions
Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. That’s why GlobalSubmit and Cato Research are offering a free educational webinar on the FDA Review Process on Tuesday, 01 March at 3:00 PM ET. Continue reading
Posted in eCTD, Regulatory Strategy, Webinars
Tagged Cato Research, DIA, eCTD, FDA, GlobalSubmit, RAPS, rev, submissions, webinar
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Top Reasons to Adopt eCTD Viewing Software
The audience for the eCTD viewer at a drug company ranges from a few users to hundreds or even thousands, depending on the size of the company. Essentially, anyone who writes content, communicates with the FDA, or creates a submission should be using eCTD viewing software. And yet, despite the many advantages and increased global adoption of eCTD submissions, there are still questions and concerns around implementation, in particular among the smaller IND companies. Continue reading
