Thompson Interactive - Enforcement or Scientific Collaboration? The Brave New World of FDA Risk Assessment
Event | 06.17.10, 12:00 AM UTC - 12:00 AM UTC
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?
Insights
Event | 12.04.25
ACI 30th Annual Conference on Drug & Medical Device Litigation
Dan Campbell with Speak on the panel "Mastering MDL Case Management: What Proposed Rule 16.1 Really Means for Consolidated Litigation."
Rule 16.1 attempts to guide early case management in MDLs, impacting litigation pace and costs. Permissive language like “should” instead of “must”, could lead to inconsistent applications. This panel will explore the rule’s anticipated impact and implications for procedures.
Event | 12.03.25 - 12.04.25
Caroline Brown to Speak at ACI New York Forum on Economic Sanctions
Event | 11.04.25
