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AdvaMed and other industry groups comment on FDAs recent draft guidance on The Special 510(k) Program, suggesting that the documen...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

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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

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

NEJM Perspective Touts Sentinel Success After 10 Years

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

Updated Policy on CDER Drug Shortage Management

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CDER posts a Manual of Policies and Procedures to update policy on Drug Shortage Management.

Meridian Gains Clearance for Cytomegalovirus Detector

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FDA clears a Meridian Bioscience de novo submission for a new diagnostic test to aid in detecting a type of herpes virus called cy...

GAO Faults FDA on Orphan Drug Records

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A new Government Accountability Office report recommends that FDA ensure that information from orphan drug designation application...

Draft Guide on Blood Glucose Monitoring 510(k)s

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Federal Register notice: FDA makes available a draft guidance entitled Blood Glucose Monitoring Test Systems for Prescription Poin...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

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Federal Register notice: FDA makes available a draft guidance entitled Self-Monitoring Blood Glucose Test Systems for Over-the-Cou...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

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