FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Comments Sought on International Drug Restrictions

[ Price : $8.95]

Federal Register Notice: FDA seeks written comments on World Health Organization recommendations to impose international manufactu...

FDA Advisers Vote Against 2 of 3 Ketek Indications

[ Price : $8.95]

Two FDA advisory committees vote against two of three indications for Sanofi-Aventis troubled antibiotic Ketek, and recommend a bl...

Elan, Biogen Idec Seek New Tysabri Indication

[ Price : $8.95]

Elan Corp. and Biogen Idec file a supplemental BLA for Tysabri, indicated for treating moderate to severe active Crohns disease.

New Trasylol Labeling Limits Patient Population

[ Price : $8.95]

FDA approves seven changes to labeling for Bayers Trasylol.

People Want More Safety, Side Effects Info

[ Price : $8.95]

Respondents to a Pharmaceutical Safety Institute survey say they want more information on drug side effects and safety issues.

Baxter Conditional Approval on Colleague Pump Correction

[ Price : $8.95]

FDA gives Baxter Healthcare conditional approval for a plan to correct its troubled Colleague drug infusion pump.

New Info Could Increase Doc DTC Support

[ Price : $8.95]

Physicians participating in Sermos online community say they could support DTC ads that better explained relative and individual r...

Merck Plans Vaccine Production Boost in New Facility

[ Price : $8.95]

Merck intends to expand a vaccine manufacturing production facility in Durham, NC to support its growing vaccine business.

Epix to Appeal to Galson Over Vasovist

[ Price : $8.95]

Epix Pharmaceuticals says it will appeal a finding last August that its blood-pool imaging agent Vasovist had not been shown safe ...

DTC Letters Have Limited Effectiveness: GAO

[ Price : $8.95]

The Government Accountability Office says FDAs inability to systematically determine which DTC ads to review and the length of tim...