May 4, 2026 | Cosmetics, Extra Article
The FDA has issued a warning letter citing the inappropriate use of artificial intelligence in pharmaceutical manufacturing, raising new concerns around cGMP compliance, data integrity, and oversight. This development signals increased regulatory scrutiny on how AI is implemented within quality systems and production processes.
Apr 21, 2025 | Extra Article
In Memoriam: Bruce Elsner We have sad news to share on the passing of Bruce Elsner who was a long-time member of the EAS family and consulting team. Bruce had over 28 years of experience working in FDA regulated Fortune 500 companies, who manufactured and packaged...
Aug 28, 2024 | Drug and Device Corner, Drugs, Extra Article, Medical Devices
FDA issued a proposed administrative order to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for OTC human use, as currently described in OTC Monograph M013. The proposed change will require the addition of a warning to the...
Oct 3, 2022 | Dietary Supplements, EAS in Action, Extra Article, Tobacco
EAS Consulting Group is pleased to welcome Shelly Blackwell to the EAS management team. As Senior Director for Dietary Supplements and Tobacco, she will be responsible for overseeing safety, submissions, and general regulatory intelligence under the purview of FDA,...
Jul 6, 2022 | Drugs, EASeNews, Extra Article, Medical Devices
EAS Consulting Group is pleased to welcome Lisa El-Shall to the EAS management team. As Senior Director for Drug and Device Services, she will be responsible for advising clients on FDA regulatory and GMP compliance matters related to pharmaceutical and medical device...
Feb 11, 2022 | Dietary Supplements, Drugs, Extra Article
Aligning Operations and Quality Drives Down Costs While Improving Efficiency By Mike Hughes, EAS Independent Consultant Have you ever felt like your co-workers are at a different company? Maybe, even a competitor who is trying to run you out of business? Yup – I have....
