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Medical Devices

American Contract Test Kits Recall is Class 1

FDA says the American Contract Systems recall of two test kits is Class 1.

FDA General

Califf Says Evidence Generation is Mediocre At Best

FDA commissioner Robert Califf says his tenure at FDA will focus on improving evidence generation, which he described as being mediocre, and on tackli...

Human Drugs

FDA, USPTO Outline Steps to Lower Drug Prices, Aid Competition

The heads of FDA and the U.S. Patent and Trademark Office describe joint actions they are taking to lower drug prices and boost competition.

Medical Devices

PMA for Degenerative Spondylolisthesis Implant

FDA accepts a PMA module from Empirical Spine for its LimiFlex Dynamic Sagittal Tether, a spinal implant for grade 1 degenerative spondylolisthesis pa...

Medical Devices

FDA De Novo Authorization for 2 Apollo Endoscope Systems

FDA grants de novo marketing authorization for two Apollo Endosurgery endoscopic systems used in obese patients.

Biologics

FDA Grants EUA for Novavax Covid Vaccine

FDA grants an emergency use authorization for Novavaxs Covid-19 Vaccine, Adjuvanted for preventing disease caused by severe acute respiratory syndrome...

Federal Register

AbbVies Rinvog Regulatory Review Determined

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for AbbVies Rinvoq (upadacitinib).

Medical Devices

FDA Clears Philips SmartSpeed Software

FDA clears the Philips SmartSpeed MR acceleration software.

Human Drugs

Citrus Plans I/ONTAK Lymphoma Drug BLA

Citrus Pharmaceuticals says it will submit a BLA to FDA later this year for its I/ONTAK T-cell lymphoma treatment.

Human Drugs

FDA Lifts Greenwich Flamingo-01 Trial Hold

FDA lifts its clinical hold on a Greenwich LifeSciences Phase 3 trial of the companys invasive breast cancer investigational treatment.