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Author Archives: BJ Witkin

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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Electronic Submissions for Paper People – Should You Do Your Own eCTD Publishing?

December 3, 2015 | BJ Witkin, Senior Manager | Regulatory Operations

Now that FDA has mandated electronic submissions, many small and mid-size pharma companies are faced with a decision: should we publish our applications ourselves or should we outsource it?

It’s actually a very easy question to answer: unless you’re a company with a large volume of submissions, you should outsource your publishing.

I know some of you read that and thought, “Well of course he says that! He works for a publishing provider.” Please allow me to back up my statement.

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Electronic Submissions for Paper People – How Valid Is Your Validator?

October 15, 2015 | BJ Witkin, Senior Manager | Regulatory Operations

We’ve talked about what goes in an eCTD submission, what you (or your publisher) need to create one, what kind of information your publisher will ask you for at the start of a new application, and lifecycle and linking. This time we’re going to discuss another term thrown around the eCTD world a lot: Validation.

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