Experts See Industry Collaboration on IVAT FDA Draft Doc as Novel Approach | GenomeWeb

A draft guidance document recently submitted to the FDA, in which Roche, Gen-Probe, and Becton Dickinson suggests a new regulatory category of in vitro diagnostic tests, represents, at the least, a new approach by industry, said a former manager at the FDA.

“Although there has frequently been cooperation between FDA and industry on guidance, this is the first time anything like this has come out of the blue from industry,” said Harvey Rudolph, who left the FDA to work as global program manager for medical devices, Underwriters Laboratories.

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