FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

MDR Violation at Nemschoff Chairs

[ Price : $8.95]

FDAs Minneapolis District Office warns Nemschoff Chairs about Medical Device Reporting violations involving its Serenity patient c...

FDA Extends Review of Novartis Myeloma Drug

[ Price : $8.95]

FDA extends by three months its review of a Novartis NDA for LBH589 (panobinostat) for use in combination with bortezomib and dexa...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Avena Botancials, Bodyhealth.com, Ebola-C Inc., Excelsior Medical, Navilyst Medi...

Guidance on Laparoscopic Power Morcellators

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Product Labeling for Laparoscopic Power Morcellators.

QS Violations Detailed at 2 Navilyst Facilities

[ Price : $8.95]

FDAs New York District Office warns Navilyst Medical about Quality System violations at two facilities that are specification deve...

FDA Safety Alert on New Biogen MS Drug

[ Price : $8.95]

FDA issues a drug safety alert on Biogen Idecs new multiple sclerosis drug Tecfidera (dimethyl fumarate) after the company confirm...

Global Drug Spend on the Rise Next 5 Years: IMS

[ Price : $8.95]

A new IMS Health reports says that global drug spending is forecast to grow at a 4-7% compound annual rate over the next five year...

Industry Faults FDA Refuse to Receive ANDA Guidance

[ Price : $8.95]

The Generic Pharmaceutical Association and other commenters say an FDA proposal to refuse to receive an ANDA due to lack of justif...

Teva Adds Info to Copaxone Petition

[ Price : $8.95]

Teva submits more supplementary information to support a petition asking FDA not to approve any ANDA for a Copaxone generic unless...

Customed Class 1 Recall of Surgical Kits

[ Price : $8.95]

Customed, Inc. begins a Class 1 recall of its sterile convenience surgical kits-trays because they have a potential package integr...