FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Intersect Ent PMA Approved for Sinus Implant Delivery

[ Price : $8.95]

FDA approves an Intersect Ent PMA for its Straight Delivery System for use in placing its Propel Mini steroid-releasing implant in...

Fortamet Not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that Andrx Labs Fortamet (metformin hydrochloride) extended-release tablets was not withdr...

Draft Guide on Pediatric Disease Priority Vouchers

[ Price : $8.95]

FDA issues a revised draft guide on Rare Pediatric Disease Priority Review Vouchers.

Latest Federal Register Notices

[ Price : $8.95]

FDA Review posts the Federal Register notices for the week ending 7/26/2019.

Guide on Kidney Transplant Delayed Graft Function

[ Price : $8.95]

FDA posts a guidance entitled Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.

Metal Expandable Biliary Stents Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Metal Expandable Biliary Stents Premarket Notification (51...

Drug Pricing Bill Advances in Senate

[ Price : $8.95]

The Senate Finance Committee votes 19-9 to advance the Prescription Drug Pricing Reduction Act.

Black Box Warning Added to Pfizers Xeljanz

[ Price : $8.95]

FDA approves a Black Boxed warning about an increased risk of blood clots and death with Pfizers tofacitinib (Xeljanz, Xeljanz XR)...

MiRus Cygnus Anterior Cervical Plate System Cleared

[ Price : $8.95]

FDA clears a MiRus 510(k) for the Cygnus Anterior Cervical Plate System.

Breakthrough Status for Arginase 1 Deficiency Candidate

[ Price : $8.95]

FDA grants Aeglea BioTherapeutics a breakthrough therapy designation for pegzilarginase, indicated for treating Arginase 1 Deficie...