FDA CDER/CBER Position on Use of SI Units for Lab Tests

January 16, 2014

FDA published a statement about their evaluation of potential transition to acceptance Lab data results in SI units instead of currently preferable US Conventional units.

Sponsors are advised to talk with the agency to discuss this topic in early stages of product development to minimize potential risks during their regulatory submissions. 

See details on http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm372553.htm

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