Risk Evaluation and Mitigation Strategy (REMS) Public Meeting
The Food and Drug Administration (FDA) is announcing a 2-day public meeting to obtain input on issues and challenges associated with the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs. As FDA has taken steps to implement the REMS provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), some stakeholders have raised concerns about the impact of various REMS, and the growing number of REMS, on the healthcare system, as well as on individual prescribers, pharmacists, distributors, and other affected stakeholders. To obtain public comment about REMS for drugs and their impact, and to gather additional input on a draft guidance issued on October 1, 2009 entitled, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,” FDA has decided to hold this public meeting. FDA wishes to give a wide range of stakeholders the opportunity to provide comment in this area. FDA will take input from the meeting into account in its development of guidance regarding REMS for drugs.
Date(s): July 27-28, 2010
Time: 8:30 a.m. to 4:30 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Ave, Building 31, Room 1503
Silver Spring, Maryland 20993
- Federal Register Notice (PDF - 137KB)
- Agenda (PDF - 46KB)
- Transcript: Tuesday, July 27, 2010 (PDF - 3MB)
- Transcript: Wednesday, July 28, 2010 (PDF - 3MB)
FDA will not be making any presentations during the REMS Public Meeting; therefore, this Webinar was developed to provide an overview of the statutory provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) as they relate to FDA’s authority to require Risk Evaluation and Mitigation Strategies (REMS). Information on how FDA has been implementing these new REMS authorities and our objectives in applying the REMS authorities is also provided.
Please use the following link to access this webinar:
All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB) for directions and further details about transportation and lodging. Map of White Oak Visitor Parking (PDF - 105KB)
Webcast of Meeting
For those unable to attend in person, the meeting will also be webcast. Watch the webcast on July 27 and July 28 from 8:30 am to 4:30 pm. Requirements and instructions for accessing the webcast are below.
You may access the webcast on July 27 and 28, 2010, via this link:
Adobe Connect Minimum Requirements:
- View meetings on Windows, Macs, Unix, and Linux platforms
- Lan or Broadband internet connection
- Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL
- Adobe Flash Player (no other downloads needed)
- VPN and Parachute compatible but not required
- Test my computer for Adobe Connect-Readiness
Attendance and Registration to Speak:
The FDA Conference Center at the White Oak location is a federal facility with limited seating so attendance will be on a first come-first served basis.
Individuals who wish to speak must register by sending an e-mail to REMSpublicmeeting@fda.hhs.gov by July 6, 2010 and provide complete contact information for each speaker, including name, title, affiliation, address, e-mail, and phone number. FDA will do its best to accommodate requests to speak and will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin.
If you need special accommodations because of disability, please contact Kristen Everett, Center for Drug Evaluation and Research, Food and Drug Administration, phone (301)796-0453, e-mail REMSpublicmeeting@fda.hhs.gov at least 7 days before the meeting.