FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Unique Device Identifiers Can Benefit Stakeholders: FDAers

[ Price : $8.95]

CDRH staffers Thomas Gross and Jay Crowley tout the benefits of the agencys proposed unique device identifier system.

FDA Accepts Glaxo/Theravance COPD NDA

[ Price : $8.95]

FDA accepts for review a GlaxoSmithKline and Theravance NDA for their once-daily investigational medicine Relvar for treating pati...

Forest Files Levomilnacipran for Major Depressive Disorder

[ Price : $8.95]

Forest Laboratories and Pierre Fabre Laboratories submit an NDA to FDA for levomilnacipran to treat major depressive disorder.

Drug Firm Settlements Help Finance Medicaid Enforcement

[ Price : $8.95]

A Public Citizen report update finds that states are increasingly settling fraud cases with drug companies and making enough money...

FDA Needs Tighter Control on Device Hacking Potential: GAO

[ Price : $8.95]

A new GAO report finds that FDA has not considered intentional information security risks or device hacking as a realistic possibi...

FDA OKs Bayers Stivarga for Advanced Colorectal Cancer

[ Price : $8.95]

FDA approves Bayer Healthcares Stivarga to treat patients with colorectal cancer that has metastasized after treatment.

Ariad Submits Rolling NDA for Leukemia Drug

[ Price : $8.95]

Ariad Pharmaceuticals completes a rolling NDA for its investigational BCR-ABL inhibitor, ponatinib, for treating patients with cer...

Broader Accelerated Approvals Urged in White House Report

[ Price : $8.95]

A new White House report urges an expanded accelerated approval programs and limited approvals to increase the number of innovativ...

Depomed Sues FDA Over Gralise Non-Orphan Exclusivity

[ Price : $8.95]

Depomed sues FDA over the agencys refusal to grant Orphan Drug exclusivity to its drug, Gralise (gabapentin), and its use in manag...

FDAs Skin Wash Designation Arbitrary and Capricious: Court

[ Price : $8.95]

DC federal court judge Rosemary Collyer faults FDA for its determination that Prevors skin wash product is a combination product w...