Thompson Interactive - Enforcement or Scientific Collaboration? The Brave New World of FDA Risk Assessment

In this 90 minute audio conference, Cathy Burgess will discuss the pattern of recent warning letters and give participants pointers on FDA’s current areas of focus. In addition, Cathy will provide tips on how to avoid warning letters and how to respond if you receive one.

Learning Points and Questions To Be Answered:

• Will FDA take enforcement action or “wait and see”?
• Are these inconsistent approaches?
• Can industry anticipate how the agency will respond to a problem?