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FDA head pushes for mandated lead testing by food manufacturers

The head of the U.S. Food and Drug Administration (FDA), Dr. Robert Califf, pushed lawmakers on Thursday to pass a bill that would mandate that food manufacturers perform testing for lead in their products that are getting imported into the country from overseas. Califf’s call to action came while he was answering questions from Rep.…

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FDA urges Congress to pass bill mandating food manufacturers test for lead

The U.S. Food and Drug administration is urging Congress to pass legislation to mandate food manufacturers to test imported products for lead.

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U of I startup gets distribution deal for sepsis AI diagnostic tool

Prenosis, which is based in Chicago, has announced that it will work with Roche Diagnostics to bring its Sepsis ImmunoScore tool to hospitals across the country.

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Potato Salad, Ice Cream Sandwiches & Gelato Recalled For Undeclared Allergens

The U.S. Food and Drug Administration announced recalls of Kowalski Simply Sides - Jack's Potato Salad by Hamtramck, Michigan-based Home Style Foods, Inc. as well as Ice Cream Sandwiches and Gelato by Fort Myers, Florida-based Belgian Yummies, citing undeclared allergens.

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Federal court orders Philips Respironics to stop manufacturing sleep apnea machines at 3 Pittsburgh-area facilities

The company responsible for a global recall of sleep apnea machines is now legally barred from resuming production at U.S. facilities until it meets a number of safety requirements.

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U.S. FDA approves expanded use of J&J's cancer cell therapy

The U.S. Food and Drug Administration on Friday allowed the expanded use of Johnson & Johnson and Legend Biotech's Carvykti cell therapy as an earlier treatment for patients with a type of blood cancer.

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Scientists urge FDA to rescind approval of test for opioid addiction risk

A group of public health experts and scientists is calling on the Food and Drug Administration to rescind its controversial approval of a DNA test that promises to predict genetic risk of opioid addiction. In a letter sent to the agency on Thursday, 31 experts in genetics, addiction, psychiatry and medical-device regulation called the approval of AvertD a mistake that relied on faulty science and puts patients at risk. The group sent a separate letter to the Centers for Medicare and Medicaid Ser

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