This duct-tape approach might pass an audit today, but it won’t survive the rigor of future scrutiny, nor the growing ...

An independent vaccine advisory group said on Thursday it will conduct a scientific evidence review of a vaccine used to ...

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...

AI emerged as a key differentiator in accelerating development timelines and enhancing clinical operations. Decentralized ...

Griffin, Current Chief Financial Officer and Chief Operating Officer, Appointed President and Chief Executive OfficerCheryl Blanchard to Become Executive Chair of the Board of Directors BEDFORD, Mass.

The US captured Venezuelan President Nicolás Maduro and his wife in a military operation Saturday. They face drugs and ...

Venezuelan President Nicolas Maduro has been captured and flown out of Venezuela after the US carried out a large scale strike, US President Donald Trump announced. Follow for live updates.

The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital ...

Diabeloop receives FDA 510(k) clearance for DBLG2, an Automated Insulin Delivery algorithm in an App: a strategic ...

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

Federal regulators have released a mandated report regarding the presence of "forever chemicals" in makeup and skincare ...

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...