FDA Related News

Uncertainty Rules at FDA: Henry Miller

Former FDAer Henry Miller says uncertainty rules as FDA awaits the expected confirmation of Martin Makary as commissioner.

Medical Devices

Calyxo Updates CVAC Aspiration Instructions

An FDA medical device early alert says Calyxo has issued updated instructions for using its CVAC Aspiration Systems due to its identification of a new...

Medical Devices

Baxter Spectrum Pump Recall is Class 1

FDA says the Baxter 2/5 recall of specific Spectrum infusion pumps was Class 1.

Human Drugs

FY 25 OTC Monograph Facility Fees Set

FDA publishes the FY 2025 OTC monograph drug facility fee and contract manufacturing organization fees.

Human Drugs

Complete Response on Lumbar Disc Herniation BLA

FDA sends Seikagaku a complete response letter on its BLA for condoliase, a treatment that reduces leg pain associated with lumbar disc herniation.

Medical Devices

FDA Delays Decision on Breast Cryoblation Device

FDA delays its decision on an IceCure Medical de novo marketing authorization request for the ProSense cryoblation device and its use in early-stage l...

Animal Drugs

Pancreatic Cancer Drug Gets Orphan Status

FDA awards PEP-Therapy an orphan drug designation for PEP-010 and its used for treating pancreatic cancer.

Medical Devices

BD Alaris Pump Software Being Corrected

Becton, Dickinson corrects software for the BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter after receiving reports that cu...

Federal Register

FDA Revokes EUAs on 3 Beckman Coulter Tests

Federal Register notice: FDA revokes Emergency Use Authorizations issued to Beckman Coulter for three of its Access branded Covid-19 tests.

Human Drugs

Aspen Pharmacare CGMP Violations

FDA warns South Africas Aspen Pharmacare about CGMP violations in its production of finished drugs as a contract manufacturing facility.