What are the countermeasures for the SBOM mandate under the EU CRA? Explaining the METI guidelines and vulnerability management

Driven by executive orders signed by U.S. President Biden, FDA regulations for medical devices, and the enactment of the ...
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FDA releases draft guidance for robotic surgical devices

The draft guidance outlines the testing and clinical evidence manufacturers should include when seeking authorization for ...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FDA Issues Draft Guidance on Robotically-Assisted Surgical Devices

FDA issued draft guidance outlining premarket submission recommendations for robotically-assisted surgical devices, ...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

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 ...
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 drafts guidance on best practices for responding to inspection observations

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.
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The US Food and Drug Administration (FDA) has issued a pair of draft guidance documents aimed at guiding the selection of proprietary names for prescription and non-prescription drugs.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 ...

The FDA Just Updated Its Guidance for Bagged Lettuce, Cut Fruit, and Other Ready-to-Eat Produce

Because fresh-cut produce doesn’t undergo a final step to eliminate harmful pathogens, the agency’s recommendations emphasize preventing contamination throughout the production process.
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 ...
American Hospital Association

FDA issues draft guidance on premarket submissions of robotically-assisted surgical devices

The Food and Drug Administration released draft guidance Sept. 24 that includes recommendations on non-clinical testing, ...