CBI Forum on Off-Label Guidelines

On October 11, 2012 Jose Sierra (Boston) will be speaking on a panel “An Update on Recent OPDP Warning Letters, Notice of Violation (NOV) and FDA’s Bad Ad Program” at the CBI’s 14th Annual Forum on Off-Label Guidelines.

9:30AM – 11::00 AM

An Update on Recent OPDP Warning Letters, Notice of Violation (NOV) and FDA’s Bad Ad Program

Learn which actions have been successful and which have failed.

Understand the legal theories the government is employing, including the origins of the Park Doctrine and how it is being applied.

Acquire key takeaways to improve internal compliance activities.

Speakers:

Jose P. Sierra, Principal, Fish & Richardson P.C.

Retta M. Riordan, President, Riordan Compliance LLC