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 ...

Mr. John DeLucia, as a well-respected Regulatory Consultant, is representing Izotropic in its pre-submission interactions with FDA while ensuring the Company's proposals, documentation, filings, and ...

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’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 ...

The US Food and Drug Administration on Monday approved Hikma Pharmaceuticals’ generic version of Novo Nordisk’s diabetes drug, Victoza, clearing the way for the launch of another copy of the ...