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Biologic IVD premarket review could begin without ELA data, Abbott says.

This article was originally published in The Gray Sheet

Executive Summary

IVD PRODUCT LICENSE APPLICATIONS: FDA FILING WITHOUT FACILITY DATA should be allowed under FDA biologics regulations, Abbott Diagnostics says in Feb. 3 comments to the agency. Changing the regulations to allow the filing of PLAs for in vitro diagnostic products while manufacturers collect facility and equipment validation data for the establishment licensing application (ELA) could reduce the time it takes manufacturers to file an application by six to 12 months, Matt Klamrzynski, director of Abbott Diagnostics Division regulatory affairs, said.



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