FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

St. Jude Recalls 250,000 Defibrillators

[ Price : $8.95]

St. Jude Medical recalls certain models of its Fortify, Unify, and Assura implantable cardioverter defibrillators and cardiac resy...

More Info Sought on Ulcerative Colitis Guidance

[ Price : $8.95]

Six drug companies say that additional information on various issues is needed in an FDA draft guidance on clinical endpoints for ...

Class-wide Label Warning for Testosterone

[ Price : $8.95]

FDA approves a class-wide labeling change for all prescription testosterone products, adding a new Warning and updating the Abuse ...

Inovio Pharma Phase 3 Trial on Clinical Hold

[ Price : $8.95]

FDA places a clinical hold on an Inovio Pharmaceuticals proposed phase 3 clinical program for VGX-3100, requesting additional data...

Public Meeting on Generic Drug User Fees: Correction

[ Price : $8.95]

Federal Register Notice: FDA corrects a 9/26 notice announcing a public meeting to discuss proposed recommendations for reauthoriz...

Eustachian Tube Balloon Dilation System is Class 2

[ Price : $8.95]

Federal Register Final Order: FDA classifies the Eustachian tube balloon dilation system into Class 2 (special controls).

FDA Approves Merck C-diff Recurrence Reducer

[ Price : $8.95]

FDA approves a Merck NDA for Zinplava (bezlotoxumab) injection 25 mg/mL, indicated for reducing recurrence of Clostridium difficil...

FDA Clears Ortho Clinical Automated Blood Analyzer

[ Price : $8.95]

FDA clears an Ortho Clinical Diagnostics 510(k) for the Ortho Vision Max, an automated blood analyzer for high-volume transfusion ...

Hospital Inspections Identify Need for Improved Event Reporting

[ Price : $8.95]

CDRH seeks to improve medical device post-market data by improving hospital (user) reporting of adverse events.

FDA DTC Study on Animation Activities Moving Forward

[ Price : $8.95]

FDA advances a planned direct-to-consumer (DTC) advertising study that is intended to research the growing use of animation in pre...