Members Only ContentSelf-Enforcement of Regulatory Compliance through a Culture of Credibility

Posted on November 2013 by By Joshua Axelrod, Esq., M.B.A.

At the 2013 Food and Drug Law Institute’s Advertising and Promotion Conference in September, 2013, Mary Riordan from the Office of Counsel to the Inspector General, Department of Health and H...read more

Members Only ContentAttack on Multiple Fronts in Nutraceutical Marketing: The threat of FTC, FDA and Consumer Class Actions

Posted on November 2013 by By Kim M. Schmid, Jenny Young, Katherine Fillmore

Nutraceutical products recently have been the subject of a multitude of class-action lawsuits questioning their marketing, efficacy, and safety.  The often hyperbolic health and nutritional cl...read more

Members Only ContentUp to Their Old Devices? Why Differences in Drug and Device Promotion Standards Matter From An Enforcement Perspective

Posted on September 2013 by by John T. Bentivoglio, Jennifer L. Bragg and Maya P. Florence

While pharmaceutical manufacturers have been the most common target of government investigations for violations of advertising and promotion rules, prosecutors and other government enforcement offi...read more

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 ContentConsumer Behavior and FDA Regulation: An FDLI Dialogue

Posted on September 2013 by By Jennifer Kane, Esq, Manager, Tobacco/Drugs Portfolio; Editor

On July 24, nearly 40 participants convened in-person at the D.C. offices of Latham & Watkins LLP and via teleconference for a cross-cutting FDLI Dialogue program focused on consumer behavior a...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 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 pro...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