EAS is pleased to announce that Independent Advisor for Food Law and Regulation, Steve Armstrong, is the winner of the 2018 Food Drug Law Institute’s Service to FDLI Award. Mr. Armstrong, the former Chief Law Council for the Campbell Soup Company, joined EAS as an Independent Advisor in 2016 and has been instrumental in assisting… Read More

At TMAs 103rd Annual Meeting held on Tuesday, April 10, 2018, CTP Director Dr. Mitch Zeller confirmed that FDA is actively working on a number of priorities that he called “Foundational Rules and Guidances”.  This includes the issuing of the Tobacco Product Manufacturing Practice (TPMP) Rule. Read more about this announcement here. EAS offers a… Read More

EAS Consulting Group would like to bring to your attention an FDA Center for Tobacco Products announcement regarding updates to the Provisional Substantial Equivalence review process. Substantial equivalence (SE) is the most commonly used pathway by which tobacco products may obtain premarket authorization. Whether SE reports were submitted Provisionally, (products introduced into commercial distribution between… Read More

DMFs are regulatory submissions to FDA for drug substances, drug products, and/or container closures allowing FDA to review information such as confidential details about facilities, processes, components, or articles used in the manufacturing, processing, packaging, and storing of one or more APIs and/or human drugs.  DMFs are at the discretion of the DMF holder and… Read More