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Medtronic UNiD Spine Analyzer Update Cleared

[ Price : $8.95]

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

FDA Clears Onkos 3D Printed Pelvic System

[ Price : $8.95]

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

FDA Defers Action on BeiGene BLA

[ Price : $8.95]

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

Inspection of Denmark Monkeypox Vaccine Facility Completed

[ Price : $8.95]

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

FDA Debars Hampton-Bey Over Misbranded Drugs

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

CA Court Should Reject New Drug Liability Theory: WLF

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

FDA Approves 3 More Centinel Spine Disc Devices

[ Price : $8.95]

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

Bill Would Take Food From FDA Responsibilities

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

American Contract Test Kits Recall is Class 1

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

Califf Says Evidence Generation is Mediocre At Best

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