Jan 30, 2023 | FDA and USDA Regulatory Update, Foods
The U.S. Food and Drug Administration (FDA) has issued a final guidance titled Best Practices for Convening a GRAS Panel. Although in most cases general recognition of safety can be supported without convening a GRAS panel, this guidance provides information to those...
Jan 30, 2023 | Drug and Device Corner, Drugs, Medical Devices
On 29 December 2022, the U.S. President signed H.R 2617 – the Consolidated Appropriations Act, 2023 into law which includes the Food and Drug Omnibus Reform Act. Of particular interest in this legislation for EAS drug and device clients, are the following: The...
Jan 4, 2023 | Drugs, FDA and USDA Regulatory Update
What You Need to Know The U.S. Food and Drug Administration has issued a final guidance on Homeopathic Drug Products describing the agency’s approach to prioritizing regulatory actions for homeopathic products posing the greatest risk to patients. The agency...
Jan 1, 2023 | Foods, Issue of the Month
Importing: What Happens If Something Goes Wrong? By Nick Lahey, EAS Consulting Group Independent Consultant The U.S Food and Drug Administration (FDA) works hand and hand with U.S. Customs and Border Protection (CBP) with the import process of FDA-regulated...
Dec 22, 2022 | Drug and Device Corner, Drugs, Medical Devices
We wish you all a very happy holiday season and prosperous new year. Reminder of the deadline of 31 December 2022 for the establishment registration and product listing renewal period. For those that have not already submitted their CARES Act reporting for FY2020 and...
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...