Prepared by EAS Consulting Group Affiliates from Almater Food Technologists srl and Lexma Consulting, Italy March 9, 2017 Abstract EAS Consulting Group, LLC, leaders in FDA regulatory consulting is pleased to release a joint White Paper prepared by Italian business associate, Almater Food Technologists and Consultants srl (Italy) and LEXMA, who provide consulting services to… Read More
Prepared by Albert Yehaskel, Independent Consultant, EAS Consulting Group, LLC. November 15, 2016 Abstract If you are a currently hold a Drug Master File (DMF), are planning to submit a DMF or routinely reference these documents, you will want to read our new white paper prepared by DMF expert Albert Yehaskel. Through this white paper… Read More
Analysis of Final FDA Regulations Establishing New Reference Amounts Customarily Consumed (RACCs), New Requirements for Single Serving Containers, and Dual Column Labeling
Prepared By Bruce Silverglade, Independent Consultant, EAS Consulting Group, LLC August 25, 2016 Disclosures on the Nutrition Facts label are based on serving sizes derived from Reference Amounts Customarily Consumed ("RACCs") that are determined by FDA. FDA has changed its RACCs for dozens of food categories, affecting the amount of nutrients for customary servings of foods… Read More
Prepared by Kaiser J Aziz, Ph.D., Independent Consultant, EAS Consulting Group, LLC July 25, 2016 FDA reviews, evaluates, verifies and validates implementation of the design control requirements described in the device premarket applications (510k/ PMA). Design control requirements play a key role from the device design prototype, manufacturing process to the finished device for user needs… Read More
Prepared By Bruce Silverglade, Independent Consultant, EAS Consulting Group, LLC June 22, 2016 This White Paper provides an analysis of FDA’s final regulation amending the Nutrition Facts label, focusing on FDA’s new requirement for added sugars content disclosure and disclosing a %DV for added sugars. The impacts of other provisions of the final rule related to the… Read More
21 PART 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food
EAS presents a digital, searchable Pocket Guide of FDA’s Food Safety Modernization Act (FSMA) 21 CFR Part 117. This first in our new series of the ever-popular EAS Pocket Guides is digitized for easy on-line access and is fully searchable, enabling quick reference of FDA’s largest food safety overhaul.