Members Only ContentFDLI’s 56th Annual Conference FDA Alumni Association Honors Richard M. Cooper with Wiley Lecture Award

Posted on May 2013 by By Stephanie Barnes, Esq, Editor, Foods Team Member

FDLI’s 56th Annual conference hosted the presentation of the Food and Drug Administration Alumni Association’s Harvey W. Wiley Lecture Award. Richard M. Cooper currently Of Counsel at more

Members Only ContentCommissioner Hamburg Gives Opening Address at FDLI’s 56th Annual Conference

Posted on May 2013 by By Stephanie Barnes, Esq., Editor, Foods Team Member

“Looking back as I approach my four year mark at the FDA, it has been an extraordinary time. Each of those years has given me a clearer perspective on FDA’s more

Members Only ContentRegulation of Drug Promotion in China

Posted on May 2013 by By Feng (Jason) Ma and Nan Lou

Drug promotion presents a challenging dilemma for regulatory authorities. On one hand, advertising and promotion are important sources of drug information. Physicians report that they often use more

The Chinese have a saying that, roughly translated, means “four faces, eight places.”1 While the meaning is difficult to translate, it effectively means everything is connected in all more

Members Only ContentChina Offers New Possibilities for Drug License Transfers

Posted on May 2013 by By Katherine Wang and Shanghai Fan Yang

Introduction The Chinese pharmaceutical market is experiencing doubledigit growth and will become the world’s second-largest market after the United States by 2016, according to IMS Health. more

As part of a growing movement on the State and Federal levels to shed light on potential conflicts of interest that may affect health care providers’ treatment decisions, the more

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 more

Members Only ContentIntellectual Property Throughout the Drug Development Lifecycle: Opportunities and Challenges

Posted on September 2012 by Raymond F. Powers, III, Pharm.D., Student Intern, Office of the Ombudsman, Office of the Commissioner, U.S. Food and Drug Administration

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 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 more

Members Only ContentAlternative Substantiation Standards For Promotional Claims

Posted on September 2012 by Coleen Klasmeier and Maura Martin Norden, Sidley Austin LLP

It is commonly believed that the rule for substantiating drug promotional claims is “substantial evidence,” meaning two adequate and well-controlled clinical investigations. “ more