Is Your Company Prepared for the FDA eCTD Mandate?
Feb06

Is Your Company Prepared for the FDA eCTD Mandate?

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?  

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FDA eCTD Mandate: One Year and Counting
May05

FDA eCTD Mandate: One Year and Counting

Almost five years ago, I wrote a post outlining the process for converting a paper application into an eCTD application with FDA. As the saying goes, the more things change, the more they stay the same. Here we are in 2016, and, to the surprise of some and the consternation of many, paper applications are still alive and well. However, their days are numbered, with FDA’s eCTD mandate for certain application types set to take effect one year from today.

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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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eCTD Tips & Tricks, Part III

Hey Everyone. It has been a few months since my last entry. I trust your holidays were enjoyable. Hopefully you didn’t think about work too much. That’s what this final chapter is going to focus on, actually – not thinking about work. In the previous installments, I talked to you about the tools and teams to help you make regulatory submissions easy. But since I’m going to assume that since I left you alone there for a few...

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Transitioning from Paper to eCTD
Sep07

Transitioning from Paper to eCTD

The most frequently asked question related to the conversion from paper to eCTD is, “Are we required to resubmit everything we’ve previously submitted in paper to the ‘new’ eCTD application?” Thankfully, FDA does not require you to resubmit information that was previously submitted in paper. However, you may find it useful to occasionally “backfill” your eCTD application by resubmitting previously submitted information for the convenience of the FDA reviewers.

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