Oct 28, 2025 | Drugs, Webinar
Navigating the FDA OTC Monograph System Presented by Lisa El-Shall November 13, 2025 | 1 PM Eastern Understand your product and the regulations that apply to it! This webinar will cover the FDA OTC Monograph system in detail. Topics include understanding what active...
Oct 13, 2025 | Drug and Device Corner, Drugs, Medical Devices
REMINDER: The drug and medical device establishment registration renewal and listing certification period begins 1 October 2025. EAS is here to assist our clients with this process, do not hesitate to reach out if you need support. The agency has published their final...
Sep 16, 2025 | Drugs, FDA and USDA Regulatory Update
FDA has issued a final guidance on how the agency intends to use alternative tools in advance, in lieu of, or in support of preapproval and prelicense inspections to remotely evaluate drug manufacturing facilities named in pending applications as part of FDA’s drug...
Sep 4, 2025 | Drugs, FDA and USDA Regulatory Update, Medical Devices, Tobacco
September 04, 2025 FDA News Release Read on FDA Website The U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. The agency also released today 89 previously...
Aug 27, 2025 | Drug and Device Corner, Drugs, Medical Devices
Generic Drug User Fee Amendments (GDUFA) 2026 user fees were published in the 30 July 2025 Federal Register (link below). User fees are due 1 October 2025. User Fee Type FY 2026 ANDADMF $ 358,247$ 102,584 Program Large SizeMedium SizeSmall Size $ 1,918,377$...
Aug 7, 2025 | Drugs, FDA and USDA Regulatory Update
August 7, 2025 FDA News Release Read on FDA Website The U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of...
