ACI - FDA Enforcement

A new era in civil and criminal FDA Enforcement has begun.

Come to the one event which will guide you through the intricacies of the new regulatory requirements and compliance protocols for this new time of change and reform.

Dr. Hamburg has put the drug and device industries on notice – the FDA is accelerating enforcement actions with a fury not witnessed by regulatory and compliance professionals in over twenty years. The agency is implementing aggressive new enforcement protocols and compliance measures for which you must be well prepared.

Preeminent food and drug counsel and government enforcement experts will share insights they have gained from service at the highest levels of FDA and related agencies.

Steve Niedelman is the co-chair of this event and will be speaking about "Drafting Strategies for Your FDA 483 Response".