2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC102
Submitter : Ms. Stefanie Koch Date & Time: 10/13/2005 11:10:18
Organization : None
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Vioxx has taught us that liberalizing label langauage, or defacto minimization of actual risk through dilution of label language, has the risk of tremendous public backlash.