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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...
Contract Laboratory receives many requests from cosmetics and food companies for outsourcing their microbiology testing. Many of these companies want testing according to FDA BAM Standards. BAM stands for the FDA Bacteriological Analytical Manual (BAM). It is a US...
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...
The US FDA announced new FDA food labeling guidelines for food packaging. The new labels would reflect scientific information, "including the link between diet and chronic diseases such as obesity and heart disease". The new FDA food labeling is being done to make...
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....
According to the FDA, food allergies are becoming a more common occurrence with symptoms ranging from mild hives to severe anaphylaxis. Symptoms of a food allergy can show up within a few minutes of eating or up to two hours later. The 8 most common foods to cause...
With product safety being so important and major recalls frequently making news headlines, food contact substances testing is important for the health and safety of human consumption. In the USA, food contact surface testing is regulated by and required by the US...
In the rapidly expanding market of nutraceuticals, dietary supplements, and vitamins, ensuring product safety and compliance with regulatory standards is paramount. The United States Food and Drug Administration (FDA) plays a crucial role in establishing guidelines...
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...
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Discover the blend of science and sustainability that ensures products are...
From safety culture to a culture of safety, protecting workers from harm is...
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