Sep 27, 2022 | Drug and Device Corner, Drugs, Medical Devices
As of 26 September 2022, the U.S. Congress has yet to pass the FDA user fees bill for FY2023 which begins 1 October 2023. EAS will keep our client based informed as this situation develops. EAS wishes to announce the retirement of Ms. Susan Crane, EAS Independent...
Aug 31, 2022 | Issue of the Month
By William A. Ruskin, EAS Independent Consultant and William L. Anderson, former partner at Crowell & Moring This article is a revision of an article that first appeared in the Lexis Nexis publication Editor’s Note: Mr. Anderson is a former partner with...
Aug 31, 2022 | EASeNews, FDA and USDA Regulatory Update, Foods
FDA recently released an updated 2022 edition of the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) for both food service and food retail establishments. These standards give recommendations for designing, managing and...
Aug 30, 2022 | Drug and Device Corner, Drugs, Medical Devices
Reminder that the establishment registration and product listing renewal period begins 1 October 2022. Contact Victoria Pankovich, vpankovich@easconsultinggroup.com if you would like EAS to handle this process for you. We can pre-schedule an appointment in October,...
Aug 18, 2022 | Drugs, FDA and USDA Regulatory Update
The much anticipated Proposed Rule on Revising the National Drug Code Format was announced in the FR Vol 87, No. 141 Revising the National Drug Code. The FDA is proposing a 12 digit uniform NDC number to replace the current format of 10 digits, which when exhausted...
Aug 15, 2022 | Drugs, Issue of the Month
By Susan Crane, EAS Senior Advisor for OTC Drugs and Labeling As part of its mission to protect the public health, the FDA monitors the safety of drug products marketed in the United States. This is accomplished through laws enacted by Congress as well as regulations...
