TUMOR MARKER PMAs SHOULD INCLUDE RETROSPECTIVE STUDY DATA
This article was originally published in The Gray Sheet
Executive SummaryTUMOR MARKER PMAs SHOULD INCLUDE RETROSPECTIVE STUDY DATA if the new tumor marker is comparable in indication and performance to previously approved markers, panel member Alexander Baumgarten, MD, PhD, Yale Medical School, suggested at an Aug. 19 meeting of FDA's Immunology Devices Panel in Rockville, Maryland. "If [manufacturers] can technically demonstrate compatibility...of method to method," said Baumgarten, "then I would not want any other documentation. End of story."
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