FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Panel to Discuss Stent Thrombosis Coronary Drug-Eluting Stents

[ Price : $8.95]

Federal Register Notice: FDAs Circulatory System Devices Panel will meet 12/7-8 to discuss stent thrombosis in coronary drug-eluti...

Generic Drug Petitions Waste Time, Dont Work

[ Price : $8.95]

FDA generic drugs counsel David Read says citizens petitions which critics charge are often used by branded drug manufacturers to...

FDA Working on User Fees for Generic Drugs

[ Price : $8.95]

As resistance to user fees grows, FDA gets $100,000 to study the feasibility of extending user fees to the review of generic drugs...

Mallinckrodt Booths Misleading

[ Price : $8.95]

DDMAC wants corrective messages for misleading Mallinckrodt MD-Gastroview, Optimark booth panels.

Guidance on Blood, Plasma Deviation Reporting

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance document on biological product deviation reporting for blood and plasma establish...

Guidance on Biological Product Deviation Reporting

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance on biological product deviation reporting for licensed manufacturers of biologica...

FDA Panel Recommends Tamoxifen Label Change

[ Price : $8.95]

An FDA panel votes to recommend a label revision for breast cancer drug tamoxifen to reflect clinical evidence showing that women ...

FDA Clears InfraReDx Spectroscopic System

[ Price : $8.95]

FDA clears a InfraReDx 510(k) application to market a near-infrared spectroscopic system for examining coronary arteries.

Novartis Extends Gleevec Warning to U.S. Labeling

[ Price : $8.95]

Novartis extends a Canadian warning on Gleevec and cardiac risk to U.S. labeling.

Ex-counsel Sees Downtrodden Staff, Poverty at FDA

[ Price : $8.95]

The monthly meeting of the FDA Alliance gets a vivid picture of FDA poverty and a downtrodden staff from former FDA counsels Stuar...