FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CDER 2013 NME Approvals on Pace for Average Year: Jenkins

[ Price : $8.95]

CDER Office of New Drugs director John Jenkins says the Center has approved 26 new molecular entities (NME) through 12/6 and will ...

Pew Recommends Practices for Academic Interest Conflicts

[ Price : $8.95]

An expert task force convened by the Pew Charitable Trusts makes recommendations for conflict-of-interest policies in academic med...

FDA Approves 1st Generic Cymbalta

[ Price : $8.95]

FDA approves seven generic drug manufacturers to market a generic version of Cymbalta to treat depression.

FDA OKs Gore Viabahn Endoprosthesis

[ Price : $8.95]

FDA approves W.L. Gores Viabahn Endoprosthesis to treat stenosis or thrombotic occlusion at the venous anastomosis of synthetic ar...

Sprout Appealing FDA Flibanserin Complete Response Letter

[ Price : $8.95]

Sprout Pharmaceuticals says it is using the FDA formal dispute resolution process to appeal the agencys complete response letter t...

Boehringer Ingelheim Fined $931,000 for Lost Pradaxa Files

[ Price : $8.95]

An Illinois federal judge fines Boehringer Ingelheim $931,000 over Pradaxa development and marketing files it is unable to produce...

Lawyer Says Still No FD&C Act-FCA Clarity

[ Price : $8.95]

Attorney John Fleder says an appeals court decision failed to discuss the potential interplay between the Federal Food, Drug, and ...

Fast Track Status for Lymphoseek

[ Price : $8.95]

FDA grants Navidea Biopharmaceuticals fast track status for Lymphoseek (technetium 99m tilmanocept) injection for sentinel lymph n...

FDA Releases Labeling Changes Approved in November

[ Price : $8.95]

FDA releases labeling changes for 27 drugs approved in November, including changes to Contraindication information for three drugs...

Congressmen Want Cyber Breach Answers

[ Price : $8.95]

Leaders of the House Energy and Commerce Committee ask FDA commissioner Margaret Hamburg for details about an October cyber securi...