FDA's digital advisors could nudge the agency to clarify how its rules apply to medical applications of generative AI, including therapy chatbots.

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

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 ...

Management of healthcare shipments requires not only logistics expertise but also a deep understanding of regulatory ...

The burgeoning field of Software as a Medical Device (SaMD) offers opportunities for innovation in healthcare monitoring and delivery through mobile apps. Regulatory focus by the FDA on "device ...

The panels employ PCR techniques to test for numerous gastrointestinal bacterial pathogens using one stool swab.

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

American inspections of foreign food facilities—which produce everything from crawfish to cookies for the US market—have ...

Dr Ratankanvar H Gadhavicharan appointed as new Commissioner of Gujarat FDCA: Our Bureau, Mumbai Monday, November 3, 2025, 16 ...

CDSCO updates list of Class A non-sterile and non-measuring devices: Gireesh Babu, New Delhi Tuesday, November 4, 2025, 08:00 Hrs [IST] The Central Drugs Standard Control Organisa ...

The new EU regulation introduces Joint Clinical Assessments that will run in parallel with EMA approvals, delivering comparative effectiveness data within one month of market authorisation.

A turning point for Rafael Yuste, a neuroscientist at New York's Columbia University, came when his lab discovered it could ...