While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...

The new director of the FDA’s device center contrasted a European rule with the U.S.’s lack of mandatory reporting ...

Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal ...

The Center for Devices and Radiological Health (CDRH) is unveiling an Idea Lab as part of the Home as a Health Care Hub initiative to help innovators, providers and patients reimagine the ...

Both President Biden, and incoming President Trump, have made AI a top priority, and now the U.S. Food and Drug ...

The FDA first warned about problems with pulse oximeter accuracy in 2021. CDRH had listed draft guidance on pulse oximeters ...

The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...

Until now, an orange couldn’t be called healthy, according to U.S. Food and Drug Administration. The fruit has 70 calories, three grams of fiber and more than 100 percent of the recommended ...

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