FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Regulatory Review Period for Regenerons Kevzara

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Regeneron Pharmaceu...

Regulatory Review Period for Provepharms Provayblue

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Provepharms Provayb...

Device Industry Seeks Changes to Special 510(k) Guide

[ Price : $8.95]

AdvaMed and other industry groups comment on FDAs recent draft guidance on The Special 510(k) Program, suggesting that the documen...

New Labeling OKd for Prolieve Transurethral ThermoDilatation

[ Price : $8.95]

FDA approves a Medifocus PMA supplement for new labeling for its Prolieve Transurethral ThermoDilatation Therapy based on the resu...

Info Collection Extension for Clinical Trial Monitoring

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled: Oversight of Clinical Investigations:...

Draft Guide on Blood Glucose Monitoring 510(k)s

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Blood Glucose Monitoring Test Systems for Prescription Poin...

Draft Guide on OTC Blood Glucose Monitors

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Self-Monitoring Blood Glucose Test Systems for Over-the-Cou...

Panel to Review Amgen Osteoporosis Therapy BLA

[ Price : $8.95]

Federal Register notice: FDA announces a 1/16 Bone, Reproductive and Urologic Drugs Advisory Committee meeting to discuss an Amgen...

FDA Approves Catalyst Firdapse for LEMS

[ Price : $8.95]

FDA approves a Catalyst Pharmaceuticals NDA for Firdapse (amifampridine) 10 mg tablets for treating adults with Lambert-Eaton Myas...

NEJM Perspective Touts Sentinel Success After 10 Years

[ Price : $8.95]

A New England Journal of Medicine online perspective reviews the success on FDAs Sentinel medical product safety system that was l...