Responding to 483s and Warning Letters:Strategies for High-Stakes Communications

In this one-of-a-kind, 90-minute audioconference, noted attorneys Fredrick H. Branding and Cathy L. Burgess will present best practices and lessons learned from decades of representing drug, device and biologics manufacturers. They will demonstrate how to analyze the FDA's concerns, respond in an appropriate fashion and avoid making common mistakes that result in inadequate responses. They will examine language from actual 483 and warning letter responses and explain why the response given was good or unsatisfactory.


24/7 ENCORE Audio Presentation You'll have access to one dial-in for an archived recording of the entire 90-minute audioconference, including the Q&A period, for unlimited participants. You can dial in any time of day or night for three weeks, from April 2 – April 20, 2007. You'll also receive all presentation materials.
Audioconference Only You'll have access to one dial-in for the live 90-minute audioconference for unlimited participants! You'll also receive all presentation materials and the opportunity to ask questions by phone and email.