Apr 4, 2022 | Dietary Supplements, Drugs, Medical Devices, Seminar, Tobacco
Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes …
Dec 21, 2021 | Client Update, Tobacco
On Dec. 21, FDA issued draft guidance for industry entitled “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” The draft guidance, when finalized, would provide information and recommendations related to the validation...
Dec 1, 2021 | Tobacco, Video
Are You Ready for TPMPs? Contact EAS for assistance with all of your regulatory needs. Download our quick reference service information sheet or visit our Tobacco services page for more detailed information on how we can help you. Contact Us Tobacco Services...
Oct 12, 2021 | Client Update, Tobacco
U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products, providing additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial...
Sep 30, 2021 | Cannabis, Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month, Medical Devices, Tobacco, Veterinary
By Susan Crane, Independent Advisor, OTC Drugs and Labeling Historically, it has been straightforward for the FDA to review and monitor labeling and advertising for products under their jurisdiction, particularly drugs and medical devices. However, the widespread use...
Jun 21, 2021 | On Demand Webinar, Tobacco
PMTA Deficiency Letter Readiness and Response Preparation Part 2 of a special series focusing on CTP’s requirement of PMTA submissions With Willie J. McKinney, Ph.D., Scientific Advisor for Labstat and EAS Independent Consultant & Moderated by Michael Bond,...
