Feb 1, 2023 | FDA and USDA Regulatory Update, Foods
In a January 31, 2023 announcement, FDA proposed a vision to restructure the oversight of food safety and informed consumer choices into a new organization which will be known as the Human Foods Program. As part of this restructuring, the Center for Food Safety and...
Feb 1, 2023 | Drugs, Issue of the Month
Process and Manufacturing Optimization to Minimize Inflation Impact on the Pharmaceutical Industry By Ibrahim Khattab, EAS Independent Consultant Rising inflation rates, the Russian invasion of Ukraine and the associated rise in energy prices, and the numerous...
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...