FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Guidance on Requirements for New Type of IVDs

[ Price : $8.95]

A new draft guidance on In Vitro Diagnostic Multivariate Index Assays outlines premarket pathways and postmarket requirements for ...

Plan B Depositions Show FDA Confidence Unraveling

[ Price : $8.95]

New deposition postings on a Plan B lawsuit against FDA suggest that senior agency managers Janet Woodcock and Steven Galson felt ...

Advisors Reject Mirabel Medicals T-Scan

[ Price : $8.95]

FDAs Obstetrics and Gynecology Devices Panel recommends against approval of Mirabel Medical Systems T-Scan 2000 ED breast cancer p...

FDA Thumbs Down on Aventis Heart Drug

[ Price : $8.95]

FDA issues a non-approvable letter to Sanofi-Aventis for its NDA on its cardiovascular drug Multaq.

Lopez, Knight in GSK Heartfelt Support Program

[ Price : $8.95]

Athletes Nancy Lopez and Ray Knight kick off GlaxoSmithKlines Heartfelt Support campaign on the importance of a strong support net...

The Cure A Book and Movie to Revive Orphan Drugs?

[ Price : $8.95]

Washington commentator Robert Steeves reviews The Cure, a book and movie he predicts will have a big impact on rejuvenating a mali...

Boxed Warning for Wyeth Menopause Drugs

[ Price : $8.95]

FDAs MedWatch announces a new boxed warning for five Wyeth menopause products for cardiovascular and other risks.

Apotex Ordered to Stop Selling Generic Plavix

[ Price : $8.95]

Federal judge Sidney Stein says Apotex must stop selling generic Plavix until the court rules on its patent litigation with Sanofi...

FDA Tentatively Approves Perrigos Generic Olux

[ Price : $8.95]

FDA tentatively approves Perrigos ANDA for a generic copy of Connetics Corp.s corticosteriod Olux foam.

FDAs Guidance Agenda Published

[ Price : $8.95]

Federal Register Notice: FDA publishes its annual guidance document agenda.