Public Meeting on Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products
National Institutes of Health, Bethesda, MD
On January 11, 2007, FDA’s Center for Drug Evaluation and Research (CDER) will hold a public meeting on improving patient safety by enhancing the container labeling for parenteral infusion drug products. This will be a 1-day workshop involving FDA staff and representatives of the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). The purpose of the meeting is to explore how labels on intravenous (IV) drug products could be designed to minimize medication errors. Design issues include placement, style and type of information, the need for standard expression of strength, quantity of information, and use of color on the label.
Date: January 11, 2007
Time: 8 a.m. – 4:30 p.m.
Location: Lister Hill Center Auditorium, National Institutes of Health (NIH), 9000 Rockville Pike, Bldg. 38A, Bethesda, Maryland 20815, 301-496-4441. Parking is limited at NIH, so Metro use is recommended. Use the Medical Center Station on the Red Line. Directions
Submit written or electronic requests to speak by December 28, 2006. Written or electronic comments to the docket will be accepted until April 12, 2007.
Send Comments:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
Register for the Public Meeting (No registration is required to attend the meeting. Seating will be on a first-come, first-served basis. Only speakers need to register.)
Interested persons may request to speak at the meeting. Statements from the public will be scheduled between 2:45 p.m. and 3:45 p.m., and the time allotted for each speaker will be limited. Requests to speak at the meeting should include: (1) The specific topic or issue to be addressed, (2) a brief summary of remarks, and (3) the participant’s name, address, telephone number, and e-mail.
Jean Chung
Center for Drug Evaluation and Research (HFD-400)
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Transcripts of the hearing will be available for review at the Division of Dockets Management and on the Internet at http://www.fda.gov/cder/meeting/parenteral_labeling.htm
For further information, contact:
Jean Chung
Center for Drug Evaluation and Research (HFD-400)
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
301-796-2380
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Date created: November 29, 2006, updated March 6, 2007 |