Your monkeyfied management, lawyers, and reps need to read the whole thing, hehehe! Get clued in also from the Recothrom Product Approval Chairman's Report where Recothrom deaths were noted, hehehe!

http://www.pharmcast.com/WarningLetters/...

"The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that the promotional material for your products comply with each applicable requirement of the Act and implementing regulations.


Sincerely,

Robert A. Sausville
Director, Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research"