FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Seeks More Prolia Info, No Trials

[ Price : $8.95]

FDA asks Amgen for more information relating to its Prolia BLA for treating and preventing postmenopausal osteoporosis.

Former ACRA Taylor Rejoins FDA

[ Price : $8.95]

Former FDA associate commissioner for regulatory affairs John M. Taylor III rejoins the agency in a newly created post counselor ...

Public Citizens Lurie Appointment at FDA Worrisome for Industry

[ Price : $8.95]

Public Citizens Peter Lurie, one of industry and FDAs staunchest critics, has joined the agencys Office of Policy.

P&U Sentenced in Bextra Marketing Case

[ Price : $8.95]

A Massachusetts federal judge sentences Pfizers Pharmacia & Upjohn unit to pay a criminal fine of $1.195 billion and a criminal fo...

FDA Wants More Info on Indacaterol Dosing

[ Price : $8.95]

FDA asks Novartis for more information on proposed dosing for its indacaterol investigational brochodilator.

FDA Sends Endo Pharma Complete Response on Fortesta

[ Price : $8.95]

Endo Pharmaceuticals receives a complete response letter from FDA on its NDA for Fortesta (testosterone) 2% gel for men diagnosed ...

Prescribing Info Labeling Guidance Out

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Labeling for Human Prescription Drug and Biological Products Determining Establ...

FDA OKs Colcrys to Prevent Gout Flares

[ Price : $8.95]

FDA approves URL Pharmas colchicine-based Colcrys to prevent gout flares.

Labeling Changes Implemented for 36 Drug Products

[ Price : $8.95]

FDA approves new Boxed Warnings for two testosterone gel products and safety labeling changes for 34 other drugs.

FDA and FTC Warn Drweil.com Over H1N1 Product

[ Price : $8.95]

FDA and FTC jointly warn drweil.com on their fraudulent marketing of a product intended to prevent H1N1.