Safe Use Initiative; Public Workshop

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is announcing a public workshop entitled “Safe Use Initiative.”  This one-and-one-half-day public workshop, organized and hosted by FDA’s Safe Use Initiative Team, will communicate the status of ongoing activities and future vision for Safe Use Initiative projects.  The workshop will also offer an opportunity for the Safe Use Initiative Team to gather input and perspectives for future directions and develop collaborative, cross-sector safe medication use activities with healthcare stakeholders.  It will provide a forum to engage the healthcare community about collaborations, interventions, and metrics for ongoing and future projects to make medications safer.

We are soliciting in advance of the public workshop topics for potential Safe Use collaborations. FDA will consider all topics; however, if submitted by November 10, 2010, some topics may become the focus for more in-depth discussions and partnership development during the public workshop. When submitting a topic for consideration, please suggest how it could become a Safe Use project, e.g., other healthcare partners who might have an interest in the issue, kinds of interventions to reduce preventable harm, metrics, etc. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852.

Date(s):     November 16-17, 2010

Time:        November 16, 2010, from 8:30 a.m. to 5:00 p.m., EST.
                 November 17, 2010, from 8:30 a.m. to 12:00 p.m., EST. 

Location:    FDA White Oak Complex
                 10903 New Hampshire Avenue
                 Bldg. 31, Room 1503
                 Silver Spring, Maryland 20993–0002

• Federal Register Notice (PDF - 56KB)
• Agenda (PDF - 63KB)
• Transcript: Tuesday, November 16, 2010 (PDF - 4MB)
• Transcript: Wednesday, November 17, 2010 (PDF - 2MB)