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FDA Announces Draft Guidance on Best Practices for Convening a GRAS Panel

Sunday, November 19, 2017

(North American Meat Institute)

The Food and Drug Administration (FDA) issued draft guidance regarding best practices for convening a panel of experts to evaluate whether a substance is "generally recognized as safe" (GRAS) under the conditions of its intended use. Specifically, the draft guidance recommends identifying GRAS panel members who have appropriate and balanced expertise; taking steps to reduce the risk that bias or the appearance of bias will affect the credibility of the GRAS panel's report, including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and limiting the data and information provided to a GRAS panel to publicly available information. The draft guidance also emphasizes that using a GRAS panel does not necessarily mean that GRAS criteria have been met. FDA is accepting public comments on the draft guidance through January 16, 2018.

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