On April 23, Michael Reilly participated in the Food and Drug Law Institute (FDLI) 2013 Annual Conference, speaking on a panel on the priorities and challenges facing the FDA and the Center for Biologics Evaluation and Research (CBER). Following presentations by CBER officials, Diane Maloney, Associate Director for Policy, and Mary Malarkey, director in the Office of Compliance and Biologics Quality, Michael led the panel discussion by giving brief remarks on the complex issues facing state legislators as they try to understand the differences between biosimilars and generics and why those differences have many physicians concerned if they are not informed by a pharmacist when a biosimilar is substituted for a prescribed biologic.
The panel was moderated by Scott Cunningham, a partner with Covington & Burling LLP and also included presentations from Brian Malkin, with Frommer, Lawrence & Haug LLP and Mark S. Robbins, PhD, with DiaMedica USA, Inc.
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