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Intended for screening blood, organ, and tissue donors, the new test will improve blood safety and availability Roche announced FDA approval of cobas® Malaria test for use on cobas® 6800/8800 Systems. The test aids in reducing risks of patient infection from...
FOR IMMEDIATE RELEASEJanuary 31, 2024 The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) As CDRH moves into 2024 and beyond, the Center intends to initiate the reclassification process for...
In recent years, the FDA has identified several concerns with laboratory developed tests ( LFTs)
False or inaccurate results may result in delayed treatments
Last month, FDA commissioner Scott Gottlieb released a statement regarding the implementation of the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. One of the limitations of these acts was in regards to the drug...
Bacteriological Analytical Manual (BAM) testing is a critical process in the food and pharmaceutical industries, providing standardized methods for detecting and identifying bacterial contaminants in products. Developed by the U.S. Food and Drug Administration...
Cosmetics sold in the United States need to be in compliance with labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act, and Food and Drug Administration Regulations. These laws require...
Proper labeling helps consumers make informed choices, manage dietary needs, and avoid allergens.
It's Easter weekend, and egg dyeing is in full force! Have you ever wondered about the food color safety testing of the easter egg dyes used on Easter eggs? Food coloring, dyes, and additives are regulated by the US Food and Drug Administration. Egg dye is a food...
The US FDA recently announced it would be making changes to the way it enforces the Food Safety Modernization Act (FSMA) of 2011, an act meant to help ensure the safety of the food supply. The agency is calling the act the biggest food safety overhaul in 70 years....
Food safety is a critical concern for consumers, manufacturers, and regulatory bodies alike. One of the essential aspects of food safety is ensuring that food contact substances (FCS)—materials that come into direct contact with food—are safe and do not pose health...
Nutraceutical, dietary supplement, and vitamin testing are essential processes for ensuring the safety, quality, and compliance of products in the health and wellness industry.
The FDA has issued more than 13 food recalls in the last 7 days. The recalls were related to undeclared ingredients like soy, milk, and eggs, Listeria and E. coli, and products not being manufactured in compliance with cGMPs. The FDA posts all food recalls on their...
Looking for medical device testing? On March 12, 2015, the US Food and Drug Administration released a final guidance for medical device reprocessing entitled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” This guidance was...
The FDA is continually working to improve patient outcomes by including patients as well as their comfort and safety in the development of new drugs, biologics, and medical devices. A relatively new law, the 21st Century Cures Act, was designed as a way to bring...
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Product Manager Cristiana Bercea expands on the current needs of ultra-low...
A modern Laboratory Information Management System (LIMS) can significantly...
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