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Dispelling Misconceptions: Converting from Paper to eCTD Submissions

May 23, 2017 | B J. Witkin, Senior Manager | Regulatory Operations

Over the years I’ve heard a whole bunch of misconceptions and misunderstandings about making the change from paper submissions to eCTD. Since the deadline to convert NDAs, ANDAs, and BLAs has recently passed (May 5th, 2017) and the deadline for INDs and DMFs is now a little less than a year away (May 5th, 2018) I thought I’d address some of them.

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Key Considerations for the Upcoming Mandatory eCTD Requirement

April 27, 2017 | Kathy Elks, Principal Consultant and Jeff Golden, Associate Director | Regulatory Operations

People who work in Regulatory Affairs, and especially those in Regulatory Operations, are well aware of the fact that it is less than a month before eCTD submissions will become mandatory. Starting on May 5th, all NDAs, ANDAs, and BLAs that are submitted to the FDA must be filed in eCTD format.

Many companies have already transitioned to eCTD submissions. However, for those companies that have not transitioned to eCTD submissions, we have some things to keep in mind regarding the requirement.

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Will the FDA Change the Way it Regulates Off-Label Promotion? One Court Case that May Have Helped Pave the Way

April 13, 2017 | Ashley Godfrey, PhD, RAC, Clinical Research Scientist II | Regulatory Affairs

When it comes to off‑label promotion – promoting a prescription drug for a use that is not included in its approved labeling – the FDA has historically taken the position that doing so risks criminal misbranding of the product under the Food, Drug and Cosmetic Act (FD&CA). However, a number of recent court cases challenging this position on the basis that it violates the First Amendment rights of drug companies have paved the way for a potential change in the way FDA will be regulating off-label promotion. We are eagerly awaiting the release of a new FDA guidance on off-label communication. This guidance will be the subject of another blog post when it becomes available. But in the meantime, I thought I would briefly discuss the relevant history of one of the court cases, Amarin Pharmaceuticals, Inc. (Amarin) versus FDA, that helped put the potential policy changes in motion.

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What I Learned at the 2017 DIA RSIDM Conference

March 23, 2017 | B J. Witkin, Senior Manager | Regulatory Operations

I was fortunate enough to attend the 2017 DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum again this year. As usual for this conference, I learned a lot and got a lot out of it.

The big news this year was…the lack of big news. Let me explain.

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Emerging Key Concepts in Biosimilar Development

March 8, 2017 | Kathryn Tworkoski, PhD, Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Biosimilars are a relatively new class of therapeutics. To date, only 4 biosimilars have been approved by the FDA (ZARXIO™, INFLECTRA®, ERELZI™, and AMJEVITA®); 3 of those 4 approvals occurred within the past year, and all 4 approvals occurred within the past 2 years! In this post, we’re going to take a quick look at the FDA’s current thoughts on biosimilar development, as well as a few key concepts in the field.

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