DIA 48th Annual Meeting
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Nanotechnology: Regulatory Challenges and Opportunities
Track : Track 04: Nonclinical and Translational Development/Early Phase Clinical Development
Program Code: 307
Date: Wednesday, June 27, 2012
Time: 8:00 AM to 9:30 AM  EST
CHAIR :
 Joseph Scheeren, Bayer Healthcare Pharmaceuticals, United States
PRESENTER (S):
Ritu Nalubola, FDA, United States
 Kathleen Eggleson, University of Notre Dame, United States
 Lawrence Tamarkin, CytImmune Sciences, Inc., United States
Description
This session will provide an overview on FDA's approach on regulating products with nanotechnology. There will also be a focus on industry case studies on experiences and challenges with nanotechnology development.

Learning Objectives:
Describe the current landscape of nanomedicines from a regulator's perspective
Identify evolving trends that can impact regulatory decision making
Discuss case studies on nanotechnology development.