This conference commenced from FDLI, Editor-in-Chief, Michael Levin-Epstein. FDLI’s Intellectual Property Throughout the Drug Development Lifecycle, commenced with the first of four panel dis...read more
Introduction One of the new provisions of the Leahy-Smith America Invents Act (“AIA”), a watershed piece of patent legislation, concerns inter partes review (“IPR”) of issue...read more
Since 2009, when the second edition of Off-Label Communications: A Guide to Sales & Marketing Compliance was released, there have been many interesting and challenging developments facing drug ...read more
It is commonly believed that the rule for substantiating drug promotional claims is “substantial evidence,” meaning two adequate and well-controlled clinical investigations. “Subs...read more
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by Marc Boutin Policy Forum (Volume 2, Number 15, August 8, 2012) explores implementation options for the long-awaited Prescription Drug User Fee Act V (PDUFA V) – How Should FDA Align B...read more
by Andrew B. Ulmer and Colleen Tersmette The Leahy-Smith America Invents Act (“AIA”), enacted on September 16, 2011, provided a major reform to United States patent law and becom...read more
Co-Sponsored by AHLA by Davina S. Rosen, Esq FDLI’s two-day joint conference with the American Health Lawyers Association ("AHLA") was designed to explore issues that food, dru...read more