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Medical Devices

Medtronic UNiD Spine Analyzer Update Cleared

FDA clears a Medtronic 510(k) for its UNiD Spine Analyzer v4.0 planning platform, which includes a new Degen Algorithm for degenerative spine procedur...

Medical Devices

FDA Clears Onkos 3D Printed Pelvic System

FDA gives 510(k) clearance to the Onkos Surgical 3D personalized pelvic reconstruction system.

Human Drugs

FDA Defers Action on BeiGene BLA

FDA defers action on a BeiGene BLA for tislelizumab to treat some squamous cell carcinoma patients.

Biologics

Inspection of Denmark Monkeypox Vaccine Facility Completed

FDA completes an inspection in Denmark of Bavarian Nordics monkeypox vaccine manufacturing plant, a step that will lead to the release of thousands of...

Federal Register

FDA Debars Hampton-Bey Over Misbranded Drugs

Federal Register notice: FDA issues an order debarring Kris A. Hampton-Bey II for a period of five years from importing any drug into the U.S.

Federal Register

Regulatory Review Period for Dr. Reddys Xeglyze

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dr. Reddys Xeglyze (abametapir).

Federal Register

Hikmas Reglan Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that Hikma Pharmaceuticals Reglan (metoclopramide injection, USP) was not withdrawn due to safety or effective...

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...