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FDA Unhappy With New Label Format Submissions; Requests Clarity, Brevity

Executive Summary

Submissions to FDA in the new labeling format have thus far failed to meet agency expectations with regard to content requirements

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CDER Updates, In Brief

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...

CDER Updates, In Brief

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...

Class Labeling Issues Could Speed Adoption Of New Highlights Format

Manufacturers may have an incentive to reformat labeling of their products sooner than would otherwise be required to prevent competing firms from setting the standard for the new Highlights section, FDA Office of Medical Policy Director Robert Temple suggested

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