Over the last three years, the Health Care Fraud Prevention and Enforcement Action Team (HEAT) has recovered over $10.2 billion in healthcare fraud settlements, many involving pharmaceutical compan...read more
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
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
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
by Stephanie Barnes, Editor, Foods Team Member FDLI’s 55th Annual Conference hosted the presentation of the Food and Drug Administration Alumni Association’s Harvey W. Wiley Lect...read more
by Archita Patel, Student Writer As part of an effort to more accurately reflect the Food and Drug Administration’s (FDA) responsibilities, subject matter expertise and mandates in an ...read more
by Davina Rosen, Conference Manager, Medical Products and Tobacco Team Member “It is pretty easy to think of CBER [FDA’s Center for Biologics Evaluation and Research) as a relati...read more
by Davina Rosen, Conference Manager, Medical Products and Tobacco Team Member “Employers have heard that FDA regulates a quarter of the US economy. That creates enormous opportunities,...read more