FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

No FDA-483 in Hovione Plant Inspection

[ Price : $8.95]

FDA says the Hovione API manufacturing facility at Loures, Portugal, passed a recent pre-approval inspection.

Acrux Plans Year-end NDA for Testosterone Therapy

[ Price : $8.95]

Acrux says it is planning an NDA submission by year-end for Axiron, an underarm testosterone replacement therapy for men.

Phillips Recalls 5,400 Faulty Defibrillators

[ Price : $8.95]

Philips recalls about 5,400 HeartStart FR2+ automated external defibrillators due to a potential memory chip failure that could ma...

CGMP Problems at Ion Drug Manufacturing Plant

[ Price : $8.95]

FDAs Florida District Office warns Ion Labs of multiple cGMP violations in its manufacture of animal and human drug products and d...

Repros Therapeutics Looking to License Proellex

[ Price : $8.95]

Repros Therapeutics says its likely that the best way to address an FDA clinical hold on its Proellex trials is to license the pro...

10 Governors Support Biologics Pathway

[ Price : $8.95]

Governors of 10 states urge Congress to approve the follow-on biologic pathway developed by the Senate HELP Committee with 12 year...

FDA Warns of Possible Pharmaceutical Syrup Shortages

[ Price : $8.95]

FDA says Paddock Laboratories Ora-Sweet SF sugar free oral syrup and Humcos Cherry Syrup may be in short supply if it is used to r...

Tamiflu Authorized for Infants in Emergency Cases

[ Price : $8.95]

FDA authorizes emergency use of Tamiflu in infants less than one year of age in cases of significant exposure to 2009 H1N1 influen...

Park Doctrine May Be Coming Back

[ Price : $8.95]

Attorney John Fleder says FDA may be planning to increase its use of Park doctrine misdemeanor prosecutions of corporate executive...

Sciele Files NDA for Pediatric Drooling Drug

[ Price : $8.95]

Sciele Pharma submits an NDA for glycopyrrolate oral solution to treat chronic, moderate-to-severe drooling in pediatric patients.