FDA, CDC Address Disease Outbreak Test Development In Wake Of SARS
This article was originally published in The Gray Sheet
Executive Summary
The investigational device exemption process for diagnostic tests related to disease outbreaks should be expedited, FDA acknowledges
You may also be interested in...
Industry, FDA Coordination Key To Diagnostic Test Availability – McClellan
FDA and CDC will coordinate efforts to provide standardized specimens of severe acute respiratory syndrome (SARS) to manufacturers by year-end to aid in validating diagnostics for the disease
Industry, FDA Coordination Key To Diagnostic Test Availability – McClellan
FDA and CDC will coordinate efforts to provide standardized specimens of severe acute respiratory syndrome (SARS) to manufacturers by year-end to aid in validating diagnostics for the disease
SARS Diagnostics Workshop July 14 Would Facilitate Lab Resource Exchange
FDA's device center sees the severe acute respiratory syndrome outbreak as an opportunity to address the scientific challenges of developing new diagnostics when a disease remains ill-defined