Join Mark DuVal for a seminar on recent regulatory-related rulings, and the effect they will have on the affected industries.
Topics to be covered include:
- The U.S. Supreme Court speaks Sorrell vs. IMS Healthcare, Inc.
- The 2nd Circuit weighs in Caronia and Amarin Pharmaceuticals and soon Pacira Pharmaceuticals
- Where are the FDA and the Department of Justice at in all of this?
- How do these cases impact government theories going forward?
- Can companies promote for off-label use?
- How is it different from off-label dissemination?
- What are the risks of prosecution today?
- How do management teams and boards apply this in a practical way?
- What about the use of disclosures and disclaimers?
- Special challenges for 510(k) devices