Nov 29, 2022 | Foods, Issue of the Month, Veterinary
Originally posted on American Council on Science and Health By Jane Caldwell, Ph.D. We love our dogs and puppies. They are faithful, non-judgmental companions who delight in our presence. Many pet owners return this affection by feeding them treats. But some human...
Nov 22, 2022 | Drug and Device Corner, Drugs, Medical Devices
Reminder that December is the deadline for the establishment registration and product listing renewal period. Kindly note the FDA has tightened up their validation process for drug listings. Although repack / relabeled listings have been submitted in the past without...
Oct 26, 2022 | Drug and Device Corner, Drugs, Medical Devices
As many are aware, FY2023 FDA user fees were pending authorization from Congress which did not happen until 30 September 2022. As a result, the user fees were announced in early October 2022. Please see Federal Register links and screen shots of fee tables below....
Oct 17, 2022 | Cosmetics, Drugs, EASeNews, Foods, Issue of the Month, Medical Devices
Prevention of product contamination through an Environmental Monitoring Program is a requirement across FDA regulated industries. This ensures product safety and reduces the likelihood of an adverse event(s) for the consumer. An established EMP is required by FDA as part of a Good Manufacturing Practice (GMP) quality system.
Oct 6, 2022 | Foods, Issue of the Month
By Amy Scalin, M.S. Hearing from FDA often means one thing: The Agency has found issues with your operations that require a swift response and corrective actions. FDA uses numerous tools to notify firms of regulatory compliance enforcement. Most commonly, a firm will...
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,...