FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Sets FY 2013 Backlog Fee

[ Price : $8.95]

Federal Register Notice: FDA sets FY 2013 rate for the backlog fee associated with human generic drugs.

Purdue Wants Rigorous Tests for Generic OxyContin

[ Price : $8.95]

Purdue asks FDA to require acceptable in vitro and in vivo test results on any generic OxyContin products.

FDA Raises Cardiovascular Risk with Novo Nordisks Degludec

[ Price : $8.95]

FDA says two Novo Nordisk NDAs for insulin products under review contain data showing a potential increased risk for cardiovascula...

Novartis Slowing on Quality Issue Remediation at FDA-troubled Plant

[ Price : $8.95]

Novartis says remediating FDA-cited quality issues at the companys Lincoln, NE manufacturing facility is taking longer than expect...

FDA Clears Osseon Bone Tamp

[ Price : $8.95]

FDA clears an Osseon Therapeutics 510(k) for its Osseoflex SB steerable inflatable bone tamp for use in treating vertebral compres...

Hydrocodone Combination Abuse Potential Difficult: FDA

[ Price : $8.95]

FDA medical reviewers say it is difficult to give a definitive quantitative analysis of the abuse potential for hydrocodone combin...

FY 2013 Rates Set for Generic Drug Fees

[ Price : $8.95]

Federal Register Notice: FDA announces the rates for ANDA, Prior Approval Supplement, and Drug Master File fees for fiscal year 20...

Senators Ask FDA to Document Involvement with NECC

[ Price : $8.95]

The Senate HELP Committee requests large numbers of documents from FDA, New England Compounding Center, and the Massachusetts Phar...

R&D Decline, Sequestration Menace Innovation: Report

[ Price : $8.95]

A Research!America 2011 U.S. Investment in Health Research report finds a decline in biomedical and health research and developmen...

Help Low-income Countries with Regulation: FDA

[ Price : $8.95]

Three FDA staffers in the Office of International Programs say there is a need to help medical product regulatory systems in low- ...