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Private Company Has GRAS Information FDA Might Not Have
date:Nov 12, 2012
ustry submits GRAS notices to FDA, which does a review and notifies the applicant by letter.

According to FDA, its response will generally fall into one of three categories:


The agency does not question the basis for the notifiers GRAS determination;


The agency concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information or because the available data and information raise questions

12/22 05:14