Sep 25, 2023 | Drug and Device Corner, Drugs, Medical Devices
Reminder that FY2024 GDUFA payments are due 2 October 2023. The FDA does allow a 20 calendar day grace period, after which arrears lists will be published with the names of companies that have failed to make payment. Failure to pay required user fees by this deadline...
Sep 19, 2023 | FDA and USDA Regulatory Update
On Friday 15 September 2023, the FDA issued a draft guidance shedding light on the much-anticipated MoCRA registration and listing requirements. The guidance, titled “Registration and Listing of Cosmetic Product Facilities and Products” gives an overview of the...
Sep 8, 2023 | Foods, Issue of the Month
“Tree Nut” Allergy; Is It a Misnomer? By Lisa Zitiello, EAS Consulting Group, Independent Consultant Food safety professionals across the globe will agree that one key safety factor in food production today is the avoidance of allergen cross-contact. This is closely...
Aug 29, 2023 | FDA and USDA Regulatory Update, Tobacco
On March 10, the U.S. Food and Drug Administration published a proposed rule titled, Requirements for Tobacco Product Manufacturing Practice. FDA is extending the proposed rule’s comment period by an additional 30 days to allow people additional time to submit...
Aug 28, 2023 | Drug and Device Corner, Drugs, Medical Devices
We will be entering the establishment renewal and product listing certification period soon. As your regulatory support partner, EAS is here for any questions you may have. If you wish for us to handle the annual requirements, please email Victoria Pankovich to get...
Aug 15, 2023 | FDA and USDA Regulatory Update, Tobacco
In a major win for the premium cigar industry, Judge Amit Mehta of the U.S. District Court for Washington D.C. has vacated FDA’s deeming regulations for premium, hand-rolled cigars. As a result, the regulations introduced by the FDA in 2016 do not apply to cigars that...
