In a significant health alert, the U.S. Food and Drug Administration (FDA) has upgraded the recall of Costco’s Kirkland Signature Smoked Salmon to a Class I designation, indicating a serious health ...

The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...

To the extent that clinical trials are designed around homogeneous, not real-world diverse patient populations, how might ...

The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted ...

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...

RevMedica announced that the FDA accepted its Endo stapling platform into its Safer Technologies Program (STeP).

Medtech supplier Cortland Biomedical said the new designation positions it as a full-service contract manufacturer.

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some ...