VivoSim Labs Celebrates Updated FDA Regulations Allowing Greater use of Non-Animal Testing Methods

VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim”), a provider of next-generation New Approach Methodologies (NAM) 3d human cellular models for preclinical safety, today celebrated the U.S ...

FDA to prioritize guidance on AI, surgical robots next year

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

FDA issues draft guidance for surgical robots

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.
MobiHealthNews

FDA releases draft guidance for robotic surgical devices

The draft guidance outlines the testing and clinical evidence manufacturers should include when seeking authorization for ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Issues Draft Guidance on Robotically-Assisted Surgical Devices

FDA issued draft guidance outlining premarket submission recommendations for robotically-assisted surgical devices, ...
Cardiovascular Business

FDA shares draft guidance for cardiovascular surgical robots

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

FDA issues draft guidelines for non-opioid solutions to chronic pain

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 ...
JD Supra

FDA’s New Psychedelic Drug Guidance Paves a Path to Approval While Setting a High Evidentiary Bar

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 ...
RAPS

FDA’s device center releases guidance agenda for FY 2027

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 ...
RAPS

FDA finalizes guidance on assessing bioequivalence of topical drugs

FDA finalizes guidance on assessing bioequivalence of topical drugs The US Food and Drug Administration (FDA) has finalized guidance for manufacturers on using physicochemical and structural (Q3) ...
Healio

FDA-identified uncertainties about new cancer drugs often omitted in journals, guidelines

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 ...
Fox News

Trump administration to unveil new dietary guidelines as FDA plans sweeping 2026 food overhaul

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 ...