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.

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

FDA issued draft guidance outlining premarket submission recommendations for robotically-assisted surgical devices, ...

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 ...

The draft guidance outlines the testing and clinical evidence manufacturers should include when seeking authorization for ...

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 ...

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 ...

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

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

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) ...

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.

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 ...