A two-day public workshop on evaluating robotic surgery systems with autonomous or remote capabilities is also on the agency’s agenda, as telesurgery advances globally.

In January 2025, the FDA published the draft version of the guidance on lifecycle management for AI-enabled devices now ...

Please provide your email address to receive an email when new articles are posted on . The guidelines address issues related to development and prescription of non-opioid pain drugs. They are part of ...

FDA issued draft guidance outlining premarket submission recommendations for robotically-assisted surgical devices, establishing a regulatory framework.

Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug ...

The 50-page document outlines what the FDA would like to see as vendors submit their technologies for regulatory review. It ...

On July 13, 2026, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its guidance on “Psychedelic Drugs: Considerations for Clinical Investigations,” replacing the June 2023 draft ...

The US Food and Drug Administration (FDA) has issued a pair of draft guidance documents aimed at guiding the selection of proprietary names for prescription and non-prescription drugs. The best ...

Please provide your email address to receive an email when new articles are posted on . The FDA frequently identifies uncertainties about newly approved cancer drugs, but they are often omitted in ...

The Trump administration is preparing to roll out new dietary guidelines for Americans in early January, a move Food and Drug Administration (FDA) officials say will kick off a broader food policy ...