FDA Related News

IRB Violations Seen in FDA-483s

FDA identifies four trends in IRB violations from FDA-483s issued in FY 2023.

Medical Devices

FDA OKs LumiThera Dry AMD Treatment

FDA grants de novo authorization to LumiTheras Valeda light delivery treatment for dry age-related macular degeneration.

Human Drugs

Caris Companion Diagnostic for Cancer Approved

FDA approves Caris Life Sciences MI Cancer Seek and its use as a companion diagnostic to identify cancer patients for treatment with several targeted ...

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ACLA Views on PCCP Draft Guidance

The American Clinical Laboratory Association submits comments to an FDA draft guidance on medical device predetermined change control plans.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