FDA Official Says Vectibix/Erbitux Relabeling May Guide Sponsors on Agency's Criteria for Accepting Retrospective Data
October 07, 2009
FDA Official Says Vectibix/Erbitux Relabeling May Guide Sponsors on Agency's Criteria for Accepting Retrospective Data
Just because the sponsors performed genomic analyses on samples collected during previously completed trials doesn't mean "they went on a fishing expedition," said FDA's Lawrence Lesko, discussing the agency's re-labeling of Vectibix and Erbitux with gene-response data.
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