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Medical Devices

Assess Full Cost of Software Pre-certification: Attorney

Attorney Bradley Thompson urges the medical device industry to weigh the downstream consequences of unbridled enthusiasm for FDAs proposed software pr...

Human Drugs

Relypsa sNDA Approved for Veltassa Label Update

FDA approves a Relypsa supplemental NDA for Veltassa (patiromer) for oral suspension in treating hyperkalemia.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Biotek Inc. and Dexcowin Co.

Human Drugs

AuroMedics Recalls Ampicillin and Sulbactam Lots

FDA says AuroMedics recalled two lots of ampicillin and sulbactam for injection due to complaints that it contained red particulate matter.

Human Drugs

FDA Chief Counsel on Upcoming First Amendment Work

In her annual address to the Food and Drug Law Institute, FDA chief counsel Rebecca Wood hints that the agency is working on a guidance on manufacture...

Federal Register

FDA Corrects Docket Number on OMB Approval Notice

Federal Register notice: FDA is correcting a 4/9 Federal Register notice about OMB approval of several information collection activities.

Federal Register

Direct Rule on Biologics Inspections Withdrawn

Federal Register notice: FDA withdraws a 1/26/2018 direct final rule to amend its general biologics regulations relating to time of inspection require...

Medical Devices

De Novo Marketing of Device Spray for GI Bleeding

FDA permits the de novo marketing of Wilson-Cook Medicals Hemospray, a new device used to help control certain types of bleeding in the gastrointestin...

Medical Devices

FDA Approves CardioFocus PMA for Atrial Ablator

FDA approves a CardioFocus PMA for the HeartLight Excalibur Balloon, a next-generation technology for treating paroxysmal atrial fibrillation.

Medical Devices

Terumo Recalls Heater/Coolers to Revise Cleaning Directions

Terumo recalls its Sarns TCM and TCM II Cooling and Heating Systems and HX2 Temperature Management Systems due to revised cleaning instructions.