Speaking Engagement

The Pendulum Has Swung: Off-Label Use and a New World Order

The American Conference Institute’s 29th FDA Boot Camp
New York, NY

Blank Rome Partner Joseph G. Poluka will speak on the panel, "The Pendulum Has Swung: Off-Label Use and a New World Order," at the American Conference Institute’s ("ACI") 29th FDA Boot Camp on Friday, March 24, 2017, at 9:00 a.m. at the Millennium Broadway Hotel in New York.  The panel will discuss the hottest issues facing the FDA-regulated industry today, with an emphasis on off-label civil and criminal enforcement activity and product liability cases.

Highlights will include:

  • Labeling, Advertising, and Promotion; what you need to know to understand the issues
  • Off-Label/New Use—the past, present, and future. Claims, Defenses, and Preemption: How did we get to where we are today and where do we go from here?
  • Investigations, Enforcement, Litigation, and Defenses
  • 10 things you need to know and issues you need to follow about off-label use and promotion under the Trump Administration (FDA, DOJ, and SCOTUS)

About ACI's FDA Boot Camp

ACI’s FDA Boot Camp has been designed by leading regulatory attorneys to give professionals such as, products or patent litigators, industry in-house counsel, business executives, investors, and regulatory affairs specialists a strong working knowledge of core FDA competencies.

For more information or to register, please click here.