FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Tobacco Panel to Discuss Dissolvable Products

[ Price : $8.95]

Federal Register Notice: FDAs Tobacco Products Scientific Advisory Committee will meet 11/2 to discuss the use of dissolvable toba...

OncoGenex Amends SPA with FDA to Expand Prostate Cancer Trial

[ Price : $8.95]

OncoGenex completes an amendment of its Special Protocol Assessment with FDA to expand the inclusion criteria for its SATURN clini...

Amneal Generic Antiepileptic Out

[ Price : $8.95]

Amneal Pharmaceuticals releases a 400 mg and 600 mg first-to-market generic antiepileptic felbamate.

FDA PDUFA 5 Reauthorization Public Meeting

[ Price : $8.95]

FDA schedules a 10/24 public meeting to hear comment on proposed recommendations for the PDUFA 5 reauthorization.

Updated CPG on Marketing Unapproved Drugs

[ Price : $8.95]

FDA issues a compliance policy guide clarifying how it is exercising enforcement discretion for unapproved drugs introduced into t...

Mylan Sued On Proposed Generic Orapred

[ Price : $8.95]

Shionogi Pharma and Cima Labs file a patent infringement suit against Mylan Pharmaceuticals over an ANDA it submitted for a generi...

Changes are Coming in FDA Field Capabilities

[ Price : $8.95]

Consulting editor John Scharmann reports on current expansion of FDAs field staff and investigational capabilities.

FDA Safety Alert for Anzemet Injection

[ Price : $8.95]

A new FDA drug safety alert says Sanofi-Aventis Anzemet (dolasetron mesylate injection) should no longer be used to prevent nausea...

FDA Approves Medtronic's Cardiac CryoAblation System

[ Price : $8.95]

FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for use in treating drug refractory paroxysmal atrial f...

FDA Seeks More Data Analysis on AstraZeneca's Brilinta

[ Price : $8.95]

FDA sends AstraZeneca a complete response letter on its NDA for Brilinta (ticagrelor), requesting an additional analysis of clinic...