Selecting a CRO – an Important Consideration on the Path to Determining GRAS for a Food Ingredient
By Shawna Lemke, EAS Independent Consultant The noble pursuit of ensuring food safety is as old as time. Historians find evidence as far back as ancient Egypt and Rome of dietary laws, labeling and inspections put in place at least in part to address food safety. In...Understanding GRAS Submissions and Avoiding Data Pitfalls
Before a substance can be legally added to food in the U.S., with rare exceptions, it must be either an approved food additive or determined to be generally recognized as safe (GRAS) for use in food.
Developing a food ingredient so that it is ready for GRAS submission can be a time consuming and costly process. Understanding the major components of a GRAS submission, the details of the required sections, and factors FDA considers when reviewing GRAS submissions are imperative to a successful submission and the receipt of subsequent “No Questions” response from FDA.
Join EAS Consulting Group, leaders in FDA regulatory consulting services for a review of GRAS notification requirements, strategies to strengthen preparations and communications with FDA and avoiding GRAS dossier compilation and submission pitfalls. EAS has prepared numerous GRAS notifications, helping clients to gain a new foothold in the marketplace.
This webinar could be one of the most valuable hours of time invested all year.