China represents a huge potential opportunity for the pharmaceutical industry in both commercial and research and development spaces. In a recent survey, one of the key themes that emerged was that...read more

Members Only ContentReform of China's Food Safety Regulatory System: Are You Ready?

Posted on August 2013 by By Ying Huang and Mitchell Cheeseman

In March 2013, the annual sessions of China's National People's Congress and the Chinese People's Political Consultative Conference (referred to as the "two sessions" hereafter) caught the attentio...read more

Members Only ContentRegulatory Evolutions for Medical Devices in the EU

Posted on August 2013 by By Sarah H. Stec and Corinne Delorme

In the medical device industry, one of the largest and  most-watched regulatory overhauls is currently taking place in the European Union (“EU”). As one of the largest medical devi...read more

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 W...read more

Members Only ContentControlled Substances Regulation

Posted on May 2013 by By Jennifer Kane, Esq, Editor, Medical Products and Tobacco Team Member

On March 28, approximately 50 participants came together to hear from expert panelists and engage in discussion at FDLI’s Controlled Substances Regulation Conference. For a sec...read 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 critical...read more

Members Only ContentThe European Union Medical Device Regulations: An FDLI Webinar

Posted on May 2013 by By Davina Rosen Marano, Esq., Conference Manager, Medical Products and Tobacco Team Member

On September 26, 2012, the European Commission proposed regulations, “which aim to fill the gaps in the [current] regulatory framework and respond to the claim of inadequate safety controls,&...read 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 d...read more

Members Only ContentFCPA Resource Guide Provides Little Comfort for the Health Care Industry

Posted on May 2013 by By Edward Kane and Brian Frey

In 2012, the Department of Justice and the Securities and Exchange Commission settled twelve corporate enforcement actions under the Foreign Corrupt Practices Act (FCPA). Of those, five involved al...read 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. T...read more