FDA Related News

Human Drugs

Chinese Drug Firm Refuses FDA Record Request

FDA warns Chinas Yangzhou Hongshengding Chemical Co. about not responding to agency requests for records on its over-the-counter drug manufacturing op...

CBER SOPP on Implementing, Managing REMS

CBER publishes a Standard Operating Policy and Procedure on implementing and maintaining REMS.

Human Drugs

FDA OKs Blood Cancer Drug Tregzi

FDA approves Orca Biosystems Tregzi to improve chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers undergoing allogene...

Medical Devices

Abiomed Impella Heart Pump Recall is Class 1

FDA says the Abiomed recall of certain Impella CP Sets with SmartAssist is Class 1.

Medical Devices

Insulet Omnipod Pod Recall is Class 1: FDA

FDA says an Insulet recall of specific lots of its Omnipod Pods is Class 1.

Biologics

Blood Donor Screening in an Ebola Outbreak

FDA publishes a guidance notifying blood establishments about agency recommendations for screening and deferring blood donors in response to an Ebola ...

Human Drugs

Repeat CGMP Violations Seen in Excelvision Inspection

FDA warns Excelvision about CGMP violations in the production of drugs at its facility in Annonay, France.

Medical Devices

BMC Medical Selling Adulterated, Misbranded CPAPs: FDA

FDA warns Chinas BMC Medical that it is marketing adulterated and misbranded ventilators in the U.S. without an approved PMA in place for the devices....

Human Drugs

FDA OKs Casgevy for Younger Children

FDA approves an expanded age indication for Vertex Pharmaceuticals sickle cell drug Casgevy.

Medical Devices

Quality System, Other Violations at 3B Medical

FDA warns 3B Medical about multiple violations in its work manufacturing a software device used with ventilator systems imported from China.