eCTD Submissions Q&A

Under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Given this recent news, GlobalSubmit offered this free webinar to provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. If you were able to join us, we hope that you now feel better prepared to make the switch from paper to eCTD. We...

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FDA eCTD Review Process Q&A

Earlier this week, GlobalSubmit and Cato Research held an educational webinar on the FDA eCTD Review Process. The purpose of the webinar was to provide an overview of the various steps and stages that a drug application goes through in order to be approved by the FDA and marketed in the United States. During the webinar, GlobalSubmit’s CTO Jason Rock discussed the FDA’s workflow, the challenges they face in the electronic...

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eCTD Reviewers Guide Helpful but Not Required

In various presentations in the past, FDA speakers have mentioned the concept of an eCTD reviewers’ guide. A reviewers’ guide is not required, but can be helpful in providing a high level overview of an application.  Recently, I asked the FDA’s Office of Business Informatics (OBI) to share some thoughts about what would be useful for sponsors to provide in a user guide. They provided some guidelines as follows: If a reviewers’ guide...

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