Arctx was granted FDA 510 (k) clearance to market its flagship product, the Arctx Cool Catheter™ Set (“ACC,” “the Device”), for use in body temperature regulation. The ACC provides internal ...

Under the guidance the FDA proposed, the agency would begin overseeing biosimilars similarly to the way it regulates generics, which are copies of simpler molecules, usually pills.

The bill prohibited the FDA from enforcing regulations aimed at increasing traceability of the supply chain, among other ...

FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

The US Food and Drug Administration said Tuesday that Dr. Richard Pazdur has been named head of the Center for Drug Evaluation and Research, its largest division, which oversees the safety and ...

The Food and Drug Administration is considering whether and how to regulate therapy chatbots that are based on large language models. Today, the agency’s Digital Health Advisory Committee is meeting ...

A new industry group wants to set aside the piecemeal state-by-state approach imposing food dye and labeling laws in favor of ...

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: ...

There are strict rules about what drug companies can say in TV or print ads. But a new study shows there's a lot more wiggle ...

Artificial intelligence (AI) is increasingly integrated into drug development and regulatory decision-making; however, the regulatory landscape governing these technologies remains fragmented. While ...