FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Akebia Resubmitting Kidney Disease NDA

[ Price : $8.95]

Akebia Therapeutics completes an End of Dispute Type A meeting with FDA that discussed the companys upcoming NDA resubmission for ...

Medtronic Recalls Faulty Defibrillators

[ Price : $8.95]

Medtronic recalls its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with glassed fe...

Olympus Recalls Bronchoscopes Over Laser Compatibility

[ Price : $8.95]

Olympus recalls about 1,500 OES BronchoFiberscope BF Type devices after receiving complaints of endobronchial combustion during th...

Suggestions for Pediatric Drug Guidance

[ Price : $8.95]

Four drug stakeholders suggest changes to a draft FDA guidance on scientific considerations in pediatric drug development.

GAO Regenerative Medicine Policy Options

[ Price : $8.95]

A Government Accountability Office report on the challenges of regenerative medicine therapies and technologies offers 11 policy o...

Elevar Therapeutics NDA for Liver Cancer

[ Price : $8.95]

FDA accepts for review an Elevar Therapeutics NDA for rivoceranib, an oral tyrosine kinase inhibitor in combination with camrelizu...

CGMP Deviations at Centaur Pharmaceuticals

[ Price : $8.95]

FDA warns Mumbai, India-based Centaur Pharmaceuticals about CGMP deviations in its manufacturing of active pharmaceutical ingredie...

Outset Medical Illegally Marketing Tablo System: FDA

[ Price : $8.95]

FDA warns San Jose, CA-based Outset Medical it is illegally marketing two medical devices associated with hemodialysis.

Catalent Indiana Facility Cited in Form-483

[ Price : $8.95]

FDA gives Catalent a four-page Form FDA-483 after inspecting the firms Bloomington, IN manufacturing facility 5/4-12.

Quidel Cardio Recalls Cardiac Panel Test

[ Price : $8.95]

Quidel Cardiovascular recalls the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower-than-expected tropon...