AG/FDA Blog

FDA’s Proposed Guidance on Convening a GRAS Panel May Result in Higher Costs for GRAS Notifiers

Contributor: Mark L. Itzkoff Principal, The Law Office of Mark Itzkoff, mark@itzkofflaw.com On November 15, 2017, FDA released a proposed guidance document, Best Practices for Convening a GRAS Panel: Guidance for Industry.  The Guidance is, in part,… Read More
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FDA Finalizes GRAS Rule

FDA has published a final rule (81 Fed. Reg. 54,959 (Aug. 17, 2016)), based on its 1997 proposed rule (62 Fed. Reg. 18,937 (Apr. 17, 1997); see also 75 Fed. Reg. 81,536 (Dec. 28, 2010) (reopening comment period)), which: Clarifies the criteria for w… Read More
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FDA Notice Provides a “Backdoor” for Commenting on GRAS Notification Program

The U.S. Food and Drug Administration (FDA) today published a Federal Register Notice soliciting comments on its GRAS Notification (GRASN) Program.  “GRAS” is an acronym for the phrase “generally recognized as safe.” Under sections 201(s) an… Read More
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