3D Communications Co-Authors Scientific Article on FDA Advisory Committee Meetings for Abuse-Deterrent Opioid Formulations (ADFs)

Thursday, March 1, 2018 Drug News
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Journal of Opioid Management article offers insights on how to prepare for FDA Advisory Committee meetings on ADFs.

WASHINGTON, Feb. 28, 2018 /PRNewswire/ -- The Journal of Opioid Management has just published an article entitled,

"Insights and issues from FDA Advisory Committee meetings on abuse-deterrent opioids."

The article reviews the common issues FDA Advisory Committees consider when deciding whether to recommend approval for abuse-deterrent opioids. The authors also offer practical advice on how to prepare for these meetings based on recent relevant experience and regulatory decisions.

"FDA advisory committee meetings are a critical stage of the regulatory approval process for abuse-deterrent opioids," said Christopher Miller, MS, Scientific Lead, 3D Communications, lead author of the article. "In the last two years, the FDA has approved all of the abuse-deterrents that received a positive recommendation from the advisory committee and none of those that did not.

In addition to Mr. Miller, three experts in pain and opioid abuse co-wrote the article: Richard C. Dart, MD, PhD from the Rocky Mountain Poison and Drug Center Health and Hospital Authority, Nathaniel P. Katz, MD, MS from Analgesic Solutions and Tufts University School of Medicine, and Lynn R. Webster, MD, FACPM, FASAM, from PRA Health Sciences.

The review provides recommendations on how to:

  • prepare for both closed and open sessions of the advisory committee meeting;
  • interpret the results of physical manipulation and chemical extraction studies;
  • effectively present data to advisory committee members with different expertise; and
  • address increasing concerns among some advisory committee members about approving more opioid products.

To read this article, click HERE.

To read a recent article Chris authored in The Pharma Letter regarding opioid approval, click HERE.

About 3D Communications

Chris Miller, MS is a biostatistician guiding pharmaceutical and device teams to present data effectively for regulatory submissions and FDA advisory committee meetings. Chris is experienced in the design, analysis, and interpretation of clinical trials and holds a Master's degree in Biostatistics from the University of Minnesota.

3D Communications is a strategic communications firm that works with top executives and their teams across scientific, healthcare, technology, education, financial, and business sectors to develop and deliver successful messages and presentations. For more information, visit www.3Dcommunications.us 

Cision View original content:http://www.prnewswire.com/news-releases/3d-communications-co-authors-scientific-article-on-fda-advisory-committee-meetings-for-abuse-deterrent-opioid-formulations-adfs-300606085.html

SOURCE 3D Communications



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