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Most Common Advice We Give First Time NDA/BLA Submission Teams

June 14, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing & Corporate Communications | Medical Writing Services

Throughout the years, our staff at IMPACT has worked with many clients on marketing applications (large and small) across a variety of therapeutic areas. Each one comes with its own unique challenges, but the most interesting (and often the most exciting) are those where the client is working on a submission for the first time.

Such client teams can represent a small company bringing their first drug to market, or a first-time team within large pharma. Though their corporate atmospheres may differ, the challenges they face on their first submission can be similar.

Without further ado, here are the most common 5 pieces of advice we give to first time submission teams. [Reader’s Note: In this post I use the term “submission” to mean a marketing application (eg, NDA, BLA, MAA).]

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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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Ilana Dew, PhD Promoted to Senior Clinical Research Scientist

RESEARCH TRIANGLE PARK, NC: 20 April 2017 – In April 2017, Ilana Dew, PhD was promoted to the position of Senior Clinical Research Scientist at Impact Pharmaceutical Services, Inc. (IMPACT).

Since joining the IMPACT family in June of 2016, Ilana has made significant contributions to IMPACT’s growth and the development of our corporate culture. In the role of Senior Clinical Research Scientist, Ilana provides a variety of services for IMPACT’s clients, including authoring various types of regulatory documents (eg, meeting requests, briefing documents, study protocols, components of marketing applications [NDAs/MAAs], and clinical study reports) across many different therapeutic areas. In addition to providing high-quality drug development services to IMPACT’s clients, Ilana serves as an active member of the company’s ‘Making an IMPACT’ community outreach initiative.

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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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