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What’s on the Menu Today, FDA?

USA - May 2 2017 Continuing the pattern of delays in the implementation of a compliance date for the menu labeling final rule requirements (previously covered in our…

USDA Proposed Revisions to Nutritional Fact Panel for Meat and Poultry Products

USA - December 9 2016 On December 1, the US Department of Agriculture's (USDA’s) Food Safety and Inspection Service (FSIS) issued a proposed rule to amend the nutrition…

Robert G. Hibbert

The Meat and Potatoes of FSIS's New Strategic Plan

USA - November 10 2016 On November 2, the Food Safety and Inspection Service (FSIS or the Agency) released its Fiscal Year (FY) 2017-2021 Strategic Plan,1 which provides a…

Robert G. Hibbert

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

USA - October 4 2016 The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation…

M. Elizabeth Bierman, Michele L. Buenafe, Heather A. Dorsey

FDA Uses Summer to Issue Numerous Device Guidance Documents

USA - August 31 2016 Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active…

M. Elizabeth Bierman, Michele L. Buenafe, Heather A. Dorsey