Nov 20, 2025 | Drugs, Medical Devices, Seminar, Tobacco
The life science industries, including pharmaceutical, medical device, biotechnology, biological, tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA.
We have seen the recent trend in industry toward using cloud-based services, Software-as-a-Service (SaaS) solutions, and other technical innovations. More recently, we have begun to see newer, emerging technologies including Artificial Intelligence (AI), Machine Learning (ML) algorithms & Large Language Models (LLMs), such as ChatGPT begin to find a presence within these companies.
While life science companies tend to lag behind other markets in using these technologies, they are catching up and we are seeing much greater use of AI in the development, testing, release & management of life science products with quality and compliance. This is most predominant in the medical device industry, where we find both medical devices that include software as a product component & Software-as-a-Medical-Device (SaMD) products that function as a medical device without the need for any hardware.
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 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$...
Jul 23, 2025 | Drug and Device Corner, Drugs, Medical Devices
The FDA issued a notification on 9 July 2025 regarding an FDA Imports Review Exemption Change. The agency has rescinded the FDA review exemption that had previously been applicable to importation of certain low-value FDA regulated products. Henceforth all FDA...
Jun 24, 2025 | Drug and Device Corner, Drugs, Medical Devices
The FDA has released two proposed administrative orders for requesting minor dosage form changes to certain OTC monograph drugs. These administrative orders are open for comment. Proposed Administrative Order OTC000038 If finalized, this proposed order will specify...
