Archived Video Webcast

Public Meeting of FDA and the Industry Working Group on Risk Evaluation and
Mitigation Strategies (REMS) for Certain Opioid Drug Products

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ARCHIVED VIDEO WEBCAST
Originally broadcast live on Friday, December 4, 2009

On February 6, 2009, the Food and Drug Administration (FDA) sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. FDA met with affected sponsors on March 3, 2009, to discuss how the REMS could be designed to manage the risks while also minimizing burdens to the health care system. At this meeting, FDA encouraged sponsors to work collectively to develop a proposed REMS.

The purpose of the December 4, 2009 meeting is for FDA to hear from sponsors on the development of the REMS for these products and their views about the specific features of the REMS. Only FDA staff will be permitted to question the sponsors at the meeting. However, interested persons who attend the public meeting will be given an opportunity to provide suggestions for questions for FDA staff to ask the sponsors, at FDA’s sole discretion. For those who view this webcast on December 4 and wish to suggest a question, please email OpioidREMS@fda.hhs.gov. There will be additional opportunities for public input before FDA finalizes the elements of the REMS.

The live webcast has concluded. View a recorded version here.