Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

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

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

The U.S. Food and Drug Administration can approve new personalized treatments for rare and deadly genetic diseases based on ...

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 ...

In a commentary published by the Journal of the American Medical Association, researchers at Rutgers Health, Harvard University and the University of Pittsburgh discuss the impact of unregulated ...

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 ...

Key Takeaways Congress has approved strict new limits on THC in hemp-derived productsIndustry leaders say the changes could ...

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

At K 2025, Kraiburg TPE unveiled new food-contact and flame-retardant compounds while emphasizing recyclability, circularity ...

Artificial intelligence (AI) refers to a computer system capable of simulating human learning, understanding, problem-solving ...

WASHINGTON (AP) — Unapproved peptide drugs have become a trendy new hack among wellness influencers, fitness coaches and ...