FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Roche Begins Study in Leukemia, Myelodysplastic Syndrome

[ Price : $8.95]

Roche and Genentech begin a Phase 1b/2 study of Erivedge in patients with relapsed/ refractory acute myelogenous leukemia and rela...

FDA Approves New Specs for Discoverys Surfaxin

[ Price : $8.95]

FDA approves Discovery Laboratories updated product specifications for Surfaxin (lucinactant) Intratracheal Suspension, indicated ...

FDA Favoring CardioMEMS PMA for Heart Monitor

[ Price : $8.95]

FDA appears to be supporting approval of a CardioMEMS PMA for its Champion HF Monitoring System, an implantable pressure measureme...

Budget Impasse Should Not Affect Ongoing Product Reviews: FDA

[ Price : $8.95]

FDA says the ongoing budget impasse and partial government shutdown should not affect its routine product review process for drug ...

Ben Venue Shuttering GMP-Plagued Ohio Facility

[ Price : $8.95]

Ben Venue Laboratories says the cost of complying with GMPs at its troubled Bedford, OH manufacturing facility has led it to cease...

FDA Grants Cornerstone Pharma Orphan Drug Status

[ Price : $8.95]

FDA grants Cornerstone Pharmaceuticals an orphan drug designation for CPI-613, its lead altered energy metabolism-directed drug ca...

FDA Clears New Bausch & Lomb Lenses

[ Price : $8.95]

FDA clears a Bausch & Lomb 510(k) for its newest frequent replacement silicone hydrogel contact lenses made with MoistureSeal Tech...

UDI Implementation Will Be a Challenge: Lawyer

[ Price : $8.95]

Attorney John Smith looks at problems some companies will face in implementing FDAs new medical device tracking requirements.

FDA Approves Lupin Generic Zymaxid

[ Price : $8.95]

FDA approves a Lupin ANDA for a generic copy of Allergans Zymaxid (gatifloxacin) ophthalmic solution.

FDA Announces 10 New, Updated Medication Guides

[ Price : $8.95]

FDA releases 10 new or updated Medication Guides.