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Human Drugs

CA Court Should Reject New Drug Liability Theory: WLF

Washington Legal Foundation says a California appeals court should reverse a trial court ruling holding Gilead liable for not developing a different H...

Medical Devices

FDA Approves 3 More Centinel Spine Disc Devices

FDA approves three additional Centinel Spine cervical total disc replacement devices.

FDA General

Bill Would Take Food From FDA Responsibilities

Rep. DeLauro and Sen. Durbin sponsor legislation to create a separate Food Safety Administration that would be responsible for all food programs now i...

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).