FDA to Host Public Workshop to Discuss the Impact of Abuse Deterrent Opioids

June 16, 2017

FDA Announces Plans to Hold Public Workshop on Opioid Issues

On Wednesday, June 14th, the FDA announced plans to host a public workshop regarding the impact of opioid formulations with abuse deterrent properties.  The workshop, entitled “Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities,” will be held on July 10th and 11th, 2017, from 8:30am to 5pm.

Workshop participants will include expert panel members and interested stakeholders, who will engage in a scientific discussion “about the challenges in using the currently available data and methods for assessing the impact of opioid formulations with properties designed to deter abuse on opioid misuse, abuse, addiction, overdose, and death in the postmarket setting.”  In its Federal Register notice, the FDA notes that it is hoping participants will discuss the ways in which the analysis and interpretation of existing data could be improved, as well as the “opportunities and challenges for collecting and/or linking additional data to improve national surveillance and research capabilities in this area.”

In order to achieve these goals and help participants prepare for the workshop discussion, the FDA is publishing a paper that includes the following information:

  • A brief overview of the currently available data resources used for evaluating the impact of opioid formulations with properties designed to deter abuse
  • A summary of the key methodological issues in this area
  • An outline of the issues that the Agency would like to discuss during the workshop, including enhancing existing resources, applying new methodology, and creating new resources.

Individuals interested in attending the public workshop (either in-person or virtually via Webcast) should contact Cherice Holloway via email no later than June 26, 2017.

For additional information on FDA’s public workshop, view the Agency’s notice in the Federal Register.

The Weinberg Group has a 35-year track record of helping our clients achieve successful interactions with the FDA and we have the experience you need to do exactly that.  Contact us today to learn more about our services and how we can help you develop and submit a successful application.



Quality & Compliance Agency Alerts

June 16, 2017

First Clinical Study Report Data Published for FDA Pilot Project

On Monday, March 19th, the FDA officially began a new Clinical Data Summary Pilot Program. This program is intended to “assess the feasibility of using a different format to provide required...

Read More
Agency Alerts General Regulatory

June 16, 2017

Federal Circuit Court Requires Biosimilar Makers Participate in “Patent Dance” & Give 180-Day Notice

On Tuesday, July 5th the Federal Circuit Court announced the final decision in the case of Amgen v. Apotex, ruling that manufacturers of biosimilar products must notify their brand-name competitors...

Read More
Agency Alerts General Regulatory

June 16, 2017

Will FDA Change the Definition of “Intended Use”?

FDA released proposed regulation that would allow sponsors to determine if their product is a drug/device, or if it is not a drug/device. Last week, the Agency announced a proposed rule “to provide...

Read More