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.
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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