FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

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...

House Urges Senate to Pass User Fee Reauthorization

[ Price : $8.95]

The House Energy and Commerce Committee leadership calls on the Senate to urgently reauthorize FDAs user fee programs.

FDA Debars Hampton-Bey Over Misbranded Drugs

[ Price : $8.95]

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

Regulatory Review Period for Dr. Reddys Xeglyze

[ Price : $8.95]

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

Hikmas Reglan Not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that Hikma Pharmaceuticals Reglan (metoclopramide injection, USP) was not withdrawn due to...

CA Court Should Reject New Drug Liability Theory: WLF

[ Price : $8.95]

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.