CDER Updates, In Brief
Executive Summary
What is a reportable premarket adverse event?: FDA continues to consider how to define the serious and unexpected AEs that must be reported during the premarket period. The standard in the safety reporting rule proposed four years ago calls for "virtually everything" to be submitted, CDER Office of Medical Policy Director Bob Temple concedes at the Drug Information Association annual meeting in Atlanta, June 21 (1"The Pink Sheet" March 17, 2003, p. 9). "Nobody likes that very much and ... we're not so crazy about it either," so it is the subject of close scrutiny...
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