FDA Online Instruction for eCTD Submissions

The CDER Small Business Assistance Program recently posted a web-based training course on electronic submission in eCTD format. The primary goal and purpose of CDER’s training is to encourage sponsors to submit in eCTD format. The training explains the FDA’s policies and practices regarding electronic submissions and provides sponsors with the fundamental information needed to submit new and transition old applications to...

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Educational Webinar Recap: Preparing for the eCTD Mandate

The FDA is planning to mandate electronic submissions in 2014. Since most large pharmaceutical and biotech companies already submit electronically, the greatest impact will be to the smaller companies that do not have substantial IT infrastructure in place and lack the resources of their larger peers. Jason Rock, Chief Technical Officer at GlobalSubmit, offered greater insight into this topic during a free educational webinar,...

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Free Educational Webinar: Preparing for the eCTD mandate

Presentation Details: The FDA is planning to mandate electronic submissions in 2014. Since most large pharmaceutical and biotech companies already submit electronically, the greatest impact will be to the smaller companies that do not have substantial IT infrastructure in place and lack the resources of their larger peers. Jason Rock, Chief Technical Officer at GlobalSubmit, will provide greater insight into this topic during a free...

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Converting a Paper IND to eCTD Format
Jan22

Converting a Paper IND to eCTD Format

Conversion of a paper IND to eCTD format can be done at any time the sponsor is ready to implement eCTD. It is important to note that once an eCTD submission has been made to an application all subsequent submissions to that application must also be in eCTD format. Typically, the first submission sent to the application as an eCTD will contain the appropriate form (1571 or 356h) and cover letter indicating that all future submissions...

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Regulatory Submissions: Paper vs. Electronic

I recently attended a Pharma Regulatory Writer’s Conference in Baltimore, and I have to say that I was truly surprised by the number of companies still submitting their regulatory submissions in paper format. The migration from what is still a manually driven, physically intensive process to a simplified automated task may seem daunting, but in reality, half the battle is already won. Applications are no longer written and transcribed...

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