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Comfort Level Rising With Voluntary Genomic Data Submission

Executive Summary

Three years into FDA's Voluntary Genomic Data Submission program, companies are more comfortable with the agency's ability to separate the review of the voluntary data from regulatory actions, according to FDA Associate Director of Genomics Felix Freuh

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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...

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