FDA Related News

Human Drugs

Praise for Biological Labeling Draft Guidance

The Biosimilars Council and Biosimilars Forum praise a revised FDA draft guidance on biosimilar promotional labeling.

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FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery performance in device...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

Animal Drugs

Dog Heartworm Prevention Drug Guidance

FDA publishes a guidance with additional details on earlier guidances on evaluating the effectiveness of drugs indicated to treat heartworm in dogs.

Human Drugs

6 Observations in Cipla FDA-483

FDA releases the form FDA-483 with six observations from an inspection at a Goa, India, Cipla drug manufacturing facility.

FDA General

FDA Opening Office in Rwanda

FDA associate commissioner for global policy and strategy Mark Abdoo says the agency will support the African Medicines Agency through a new office in...

Human Drugs

FDA Modifies CAR T Cell REMS

FDA modifies the REMS for CAR T cell products to ease the burden on hospitals and their clinics.

Federal Register

Draft Guide on Diversity Action Plans

Federal Register notice: FDA makes available a draft guidance entitled Diversity Action Plans to Improve Enrollment of Participants from Underrepresen...