FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Payer Issues Seen as the Biggest Barrier to New Orphan Drugs

[ Price : $8.95]

Payer and reimbursement issuesnot sciencepose the greatest potential impediment to providing new therapies for patients with rare ...

FDA Extends Clinical Hold on Arikace

[ Price : $8.95]

FDA extends a continuing clinical hold on Insmed's Arikace (liposomal amikacin for inhalation) in patients with non-tuberculous my...

Par Sues FDA Over Off-label Restrictions

[ Price : $8.95]

Par Pharmaceutical files a declaratory judgment complaint and a motion for preliminary injunction against FDA over off-label restr...

Circulatory System Devices Panel to Discuss 2 PMAs

[ Price : $8.95]

Federal Register Notice: FDAs Circulatory System Devices Panel will meet 12/7-8 to discuss a Medtronic PMA supplement and a Cardio...

FDA Approves 'Iron Overload' Drug

[ Price : $8.95]

FDA approves an ApoPharma NDA Ferriprox (deferiprone) to treat thalassemia patients who've had a blood transfusion that caused iro...

Experts Tell How to Fund Rare Disease Drug R & D

[ Price : $8.95]

Panelists at the U.S. Conference on Rare Diseases and Orphan Products explore the role and evolution of private research foundatio...

NEJM Examines 'Pay-for-delay' Generic Settlements

[ Price : $8.95]

This week's New England Journal of Medicine includes an article by Harvard professors that examines the history of, and potential ...

Depomed Planning NDA for 'Hot Flashes' Drug

[ Price : $8.95]

Depomed says it will meet with FDA to discuss a planned NDA after announcing positive clinical trial results from a Phase 3 study ...

Bill Aims to Cut Device Regulatory Burden

[ Price : $8.95]

Three senators introduce a bill to streamline FDA regulation of medical devices.

Micromet Revises Leukemia Drug Plan Based on FDA Advice

[ Price : $8.95]

Micromet says it has revised its clinical development plan based on recent FDA advice for its lead product candidate blinatumomab ...