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Category Archives: Regulatory Operations

Submitting Drug Master File Submissions to Health Canada – Lessons Learned

November 7, 2016 | BJ. Witkin, Senior Manager | Regulatory Operations

Health Canada has recently announced two major initiatives which greatly affect regulatory submissions in general and Master Files (commonly called Drug Master Files) specifically.

First, Health Canada will now require that all electronic submissions (under 10 GB in size, which is most of them) be sent via their Common Electronic Submissions Gateway (CESG) effective January 1st of 2017. Note that this is 4 months ahead of the FDA’s mandate of May 5th, 2017 (see our previous post for details).

Second, Health Canada has released draft guidance on Master Files with very detailed changes to how they are laid out and submitted. It is very different from FDA Drug Master Files; one example is the Applicant’s Part/Restricted Part (as described below). If you haven’t read the guidance and are considering submitting to Health Canada, I urge you to read it.

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DIA RSIDM Recap: FDA’s Top 10 eCTD Validation Errors and Top 5 Reasons for Rejected Submissions

April 14, 2016 | B J. Witkin, Senior Manager | Regulatory Operations

Jonathan Resnick from FDA’s Electronic Submission Support Team spoke at the recent DIA RSIDM conference and told us the top 10 validation errors the FDA is seeing in electronic submissions. He also presented a table of the top 12 reasons for rejection. I thought I’d share these with you and discuss some of them.

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What You Missed During FDA’s Presentations at DIA RSIDM

March 23, 2016 | BJ. Witkin, Senior Manager | Regulatory Operations

As I wrote recently, I attended DIA’s RSIDM conference this year. The highlight of the conference is always FDA’s presentations—they give the opening (“FDA Update”) and closing (“Ask the Regulators”) talks. This year wasn’t as exciting as last year, when FDA broke the news about the new Module 1 and the eCTD mandate, but there was still some news. Here are the big things I heard:

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Top Two Things I Learned at DIA RSIDM

February 18, 2016 | B J. Witkin, Senior Manager | Regulatory Operations

I recently attended the DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) forum, an annual conference for people who work in Regulatory Operations and Regulatory Information. As usual, I learned some things and got some food for thought. I wanted to let you know about 2 really productive sessions I attended.

The future of eCTD: eCTD v4 and Regulated Product Submissions (RPS)

One of the best sessions I attended was called “eCTD v4/RPS: Moving Towards Implementation.” The session was moderated by Mark Gray of FDA—he’s always excellent—and 2 of the presenters were Jared Lantzy (formerly of FDA) and Joel Finkle, both of whom have been following RPS and eCTD v4 for years and really, really know their stuff.

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How to Make Publishing Clinical Summaries Easier

February 4, 2016 | BJ Witkin, Senior Manager | Regulatory Operations

One of the biggest challenges of publishing an NDA, MAA or BLA is dealing with the clinical summaries: the Summary of Clinical Safety (SCS), the Summary of Clinical Efficacy (SCE), the Integrated Summary of Safety (ISS) and the Integrated Summary of Efficacy (ISE).

Why is publishing these clinical summaries difficult? And more importantly, what can we do to make this process easier?

Why is Publishing Clinical Summaries Difficult?

Before we can understand how to make publishing clinical summaries easier, we have to first understand why they are difficult.

Here are my reasons. You may have others!

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