Global Encourages CME Stakeholders to Comment on FDA Opioid REMS Forum

Global Education Group is encouraging all interested parties to submit comments supporting CME initiatives to help address FDA opioid REMS goals.

The Food and Drug Administration and the Drug Safety and Risk Management Advisory Committee will hold a public forum May 3-4, 2016 in Washington, DC to discuss the results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS (Risk Evaluation and Mitigation Strategies). The meeting aims to identity new methods for evaluating and minimizing the burden on the healthcare system, and to help patients access drugs that fall under the REMS initiative.

The FDA has invited the general public to attend, and is encouraging interested stakeholders to submit their feedback as to what modifications, if any, are needed for the REMS program. For CME stakeholders, the FDA is specifically looking for comments on:

The use of the continuing education (CME) as a component of the REMS as a mechanism for providing prescriber training

The FDA invites the public to submit comments in one of three ways: online, by mail, or in person, in the form of a presentation. The CME coalition has added a new section to their site which highlights how to submit comments and who to contact at the FDA with questions or concerns.

While the general public is invited to attend the meeting, the FDA has also setup a live webcast that will be free for all interested stakeholders to view during the meetings. The full details of the webcast have not yet been announced, but the FDA advised that webcast information will be made available to the public at least two days prior to the open forum. The webcast will also be recorded and made into an archived webcast available for download after the meeting. For more details and information from the FDA on Opioids and REMS, please visit their website for additional information.

Posted on April 21, 2016 am30 9:12 am

Tags: , , , , , ,

No Comments