FDA Related News

Medical Devices

ACLA Views on PCCP Draft Guidance

The American Clinical Laboratory Association submits comments to an FDA draft guidance on medical device predetermined change control plans.

FDA General

RFK Jr. Says Some FDA Departments Have to Go

In an interview the day after the election, president-elect Donald Trumps top health advisor Robert F. Kennedy Jr. says there are some FDA departments...

Medical Devices

Breakthrough Designation for SeaStar Dialysis Device

FDA grants a fourth breakthrough device designation for SeaStar Medicals Selective Cytopheretic Device.

Human Drugs

9 Observations in Staska Pharmaceuticals FDA-483

FDA releases the form FDA-483 with nine observations from an inspection at the Staska Pharmaceuticals outsourcing facility in Bennet, NE.

Human Drugs

Clozapine REMS Curbs Treatment: Comments

Three mental health stakeholders call on two FDA advisory committees to recommend changes to the clozapine REMS.

Medical Devices

Zeta Gets Navigation System Improvements Cleared

FDA clears a Zeta Surgical 510(k) for its Zeta Navigation System for use with expanded instruments and enhanced hospital connectivity.

Medical Devices

Advisors Asked for ProSense Benefits, Risks

FDA raises questions to be considered by members of its General and Plastic Surgery Advisory Committee about IceCare Medicals ProSense cryoblation sys...

Human Drugs

Extended Review for Organons Vtama sNDA

FDA extends by three months its review of an Organon supplemental NDA for Vtama (tapinarof) cream and its use for treating atopic dermatitis.

Human Drugs

Objectionable Conditions at Hospital IRB

FDA warns the Kittanning, PA-based Armstrong County Memorial Hospital IRB about objectionable conditions identified in a Bioresearch Monitoring Progra...

FDA Cant Regulate AI on its Own: Califf

FDA commissioner Robert Califf says collaboration with external stakeholders is needed to adequately monitor and regulate artificial intelligence.