FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Approves Subcutaneous Heart Defibrillator

[ Price : $8.95]

FDA approves a Cameron Health PMA for the S-ICD System, a heart defibrillator with leads that can be subcutaneously implanted inst...

Drug Shortages Staff to Move to CDER Deputy Oversight

[ Price : $8.95]

CDER proposes to elevate the oversight of its Drug Shortages Staff (DSS) from the Office of New Drugs to the Office of the Center ...

Ulcerative Colitis Indication for Humira Approved

[ Price : $8.95]

FDA approves an expanded indication for Abbotts Humira (adalimumab) to include treating moderate-to-severe ulcerative colitis in a...

Final Guidance on Bronchitis Drug Development

[ Price : $8.95]

FDA finalizes a 2008 guidance on Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonar...

PhRMA Principles on Interacting with Patient Groups

[ Price : $8.95]

PhRMA adopts new principles to guide interactions between pharmaceutical companies and patient organizations in the wake of the ne...

Draft Guidance on Drugs for Treating Intra-Abdominal Infection

[ Price : $8.95]

FDA releases a draft guidance for industry to assist sponsors in developing drugs for treating complicated intra-abdominal infecti...

FDA Postpones Gastrointestinal Panel Meeting

[ Price : $8.95]

Federal Register Notice: Due to scheduling issues, FDA postpones a 10/15 Gastrointestinal Drugs Advisory Committee slated to discu...

PhRMA Brief Seeks High Court Patent Settlement Review

[ Price : $8.95]

PhRMA files an amicus brief asking the Supreme Court to resolve whether brand and generic companies can reach monetary settlements...

Biogen Idec, Swedish Orphan Plan BLA for Clotting Factor

[ Price : $8.95]

Biogen Idec and Swedish Orphan Biovitrum say they plan to submit a BLA early next year for their investigational blood clotting fa...

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.