Clinical Development Programs for Sedation Products Public Workshop

The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER) is announcing a scientific workshop to solicit information on a variety of issues related to the clinical development and use of sedation products in adult and pediatric age groups. FDA intends to take into account the information provided from this workshop as we develop FDA guidance on clinical development programs for sedation products. FDA issued a notice in the Federal Register of November 29, 2010, inviting an interested party, or parties, to facilitate an evaluation of the critical fundamentals of the science related to sedation products and to plan and conduct one or more public meetings to bring together experts in the field, including from academia, patient organizations, and industry to discuss these issues. FDA has since determined that it will facilitate the evaluation and as a next step will obtain feedback by convening this public workshop.

Date(s):   May 3, 2012

Time:       8:30 a.m. to 5:00 p.m.

Location:  FDA White Oak Campus
                   10903 New Hampshire Avenue
                   Building 31, Conference Center, the Great Room, (Room 1503)
                   Silver Spring, MD 20993-0002

• Federal Register Notice
• Agenda (PDF - 29KB)
• Presentations
• Transcript: Thursday, May 3, 2012 (PDF - 3MB)

Please note that the email address for additional information in the attached FR notice is incorrect and instead should be (http://www.fda.gov/Drugs/NewsEvents/ucm301022.htm)