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FDA issues draft guidance for surgical robots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.
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FDA Issues Draft Guidance on Robotically-Assisted Surgical Devices

FDA issued draft guidance outlining premarket submission recommendations for robotically-assisted surgical devices, ...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FDA shares draft guidance for cardiovascular surgical robots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 ...
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FDA releases draft guidance for robotic surgical devices

The draft guidance outlines the testing and clinical evidence manufacturers should include when seeking authorization for ...
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 ...

FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing

Silver Spring, MD, Sept. 21, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued a direct final rule ...
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 ...
TMCnet

Humane World for Animals Commends FDA for removing animal testing references from drug regulations

Rulemaking advances reforms sought by Humane World for Animals and Humane World Action Fund to make animal tests the ...
RAPS

FDA's proprietary name guidance seeks to avoid medication errors

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 ...
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) ...