In 2011, I wrote a guest post over at The eCTD Summit about transitioning from paper to eCTD submissions. Surprisingly, much of the advice in that post 6 years ago is still applicable, but the process is even easier today. FDA’s deadline for converting marketing applications...

If you’re reading this, you have eCTD questions or study data questions and you’re looking for an answer. If you’re submitting to FDA, it’s good to remember that you can reach out directly to FDA for help. Generally, you can expect to receive an email response...

Scanned Documents

Scanned documents are a pain point for eCTD publishers and FDA reviewers alike. No one likes them, but, unfortunately, we all have to deal with them. In their “Portable Document Format (PDF) Specifications,” FDA attempts to minimize the inconvenience of scanned documents...

ESG Accounts

Good news from FDA! On 25 July 2016, FDA announced that CROs and consultants are no longer required to register separate ESG accounts for each client. You are now only required to have one ESG account for submissions for all clients. This policy change is the latest of several...

It’s likely that you’re already preparing a Development Safety Update Report (DSUR) for submission to regulatory authorities outside the US.  If so, you will be relieved to know that FDA adopted the ICH E2F Guideline.  This means that FDA will accept the DSUR to...