FDA Related News

Medical Devices

Philips Recalls Sense XL Torso MRI Coils

Philips North America recalls its Sense XL Torso (1.5T and 3.0T) MRI coils to update use instructions due to a potential issue where the coil heats up...

Human Drugs

Groups Want Changes in Drug Labeling Guidance

Two drug company associations recommend changes to an FDA draft guidance on the content and format of labeling statements of ingredients in NDAs and A...

Medical Devices

Magellan Guilty Plea Over Misbranded Devices

Magellan Diagnostics pleads guilty in federal court to criminal charges arising from its concealment of a device malfunction that produced inaccuratel...

Human Drugs

Carvykti Improves Survival in Phase 3 Trial: J&J

J&J touts positive overall survival results of its Carvykti in a Phase 3 trial in patients with relapsed or lenalidomide-refractory multiple myeloma a...

Drug Delivery Device Guidance

FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery performance in device...

Medical Devices

Philips Updates BiPAP Ventilator Use Instructions

FDA says Philips Respironics has updated use instructions for three BiPAP ventilators in a Class 1 recall.

SCOTUS Chevron Decision Harms the Public: Coalition

The Coalition for Sensible Safeguards calls on Congress to enact Chevron deference into law following a Supreme Court decision gutting the 40-year-old...

Medical Devices

Abbott Recalls HeartMate System Monitor

Abbott Medical recalls (Class 1) its HeartMate System Monitor due to atypical behavior of the System Monitor screen.

Human Drugs

Brookfield Medical/Surgical FDA-483

FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Supplies outsourcing f...

Biologics

Complete Response on Rocket Gene Therapy

FDA issues Rocket Pharmaceuticals a complete response letter on its BLA for gene therapy Kresladi (marnetegragene autotemcel; marne-cel) for treating ...