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

For Immediate Release: April 6, 2018 Media Contacts: Allen Sayer, EAS Consulting Group, LLC Senior Director Food Consulting Services 571-447-5509 asayler@easconsultinggroup.com Kathryn Harrington, FoodMinds Senior Vice President 202-878-8312 kharrington@foodminds.com EAS Consulting Group, a leader in consulting services to FDA regulated industries and FoodMinds, a premier food and nutrition consulting and communications agency, have announced a… 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