Forward-thinking manufacturers build native compliance protocols as a workflow, not as an afterthought—a pitfall that many ...

BALTIMORE – Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for failing to meet their quality management requirements, ...

Add Yahoo as a preferred source to see more of our stories on Google. The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ device issue with certain GE ...

For quality leaders navigating FDA’s CSA guidance, AI governance requirements, and the pressure to modernize without breaking compliance—this is the guide that ...

The FDA’s CSA guidance is final. Every validation project executed the old way is time and money you won’t get back—and audit exposure you can’t afford. Here is an uncomfortable truth for quality ...

Researchers at the Icahn School of Medicine at Mount Sinai have identified a previously hidden druggable site in a cancer-related protein that could open the door toward the development of a new ...

In April 2026, Anthropic released its newest frontier model, codename Mythos, to twelve partners under a gated preview. Not general availability; the company explicitly held it back as it was ...

An early warning system for sepsis, one of the deadliest infections for hospital patients, has been approved for use by the FDA, one of the first AI-based medical tools to get clearance. The tool, ...

An early warning system for sepsis, one of the deadliest infections for hospital patients, has been approved for use by the U.S. Food and Drug Administration, one of the first AI-based medical tools ...

Please provide your email address to receive an email when new articles are posted on . The Control-IQ+ automated insulin delivery system was approved for use in pregnancy with the t:slim X2 and Mobi ...

The July 2026 advisory review could reopen compounding pathways for peptides previously curtailed in 2023 over immunogenicity, toxicity, impurity risk, and inadequate human clinical evidence.

On March 18 th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro models (CIVMs). For a field long operating without a clear regulatory ...